{ "name": "FDA AI-Enabled Medical Devices list, normalized snapshot", "tracker_version": "1.0.0", "fda_source": { "list_page": "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices", "csv_export": "https://www.fda.gov/media/178541/download?attachment", "retrieved": "2026-10-30", "list_page_content_current_as_of": "2026-09-04", "csv_sha256": "4db7f69d21acbf1632259a45b85d4744b5028f42313daa433b73020802d90402", "csv_sha256_note": "SHA-256 of the FDA CSV export with line endings normalized to LF" }, "summary": { "total": 1614, "earliest_decision_date": "1995-09-29", "latest_decision_date": "2026-06-29", "by_pathway": { "510(k)": 1553, "De Novo": 40, "PMA": 21 }, "by_panel": { "Radiology": 1230, "Cardiovascular": 154, "Neurology": 73, "Anesthesiology": 30, "Gastroenterology-Urology": 27, "Hematology": 22, "Pathology": 10, "Ophthalmic": 10, "General and Plastic Surgery": 9, "Clinical Chemistry": 9, "Orthopedic": 8, "Dental": 7, "Microbiology": 7, "General Hospital": 6, "Obstetrics and Gynecology": 5, "Clinical Toxcicology": 5, "Ear Nose & Throat": 1, "Immunology": 1 }, "by_year": { "1995": 2, "1997": 1, "1998": 2, "2001": 2, "2002": 1, "2004": 1, "2005": 1, "2006": 1, "2008": 5, "2010": 2, "2011": 3, "2012": 5, "2013": 4, "2014": 6, "2015": 6, "2016": 18, "2017": 27, "2018": 65, "2019": 80, "2020": 114, "2021": 129, "2022": 162, "2023": 226, "2024": 235, "2025": 335, "2026": 181 }, "by_year_pathway": { "1995": { "510(k)": 0, "De Novo": 0, "PMA": 2 }, "1997": { "510(k)": 1, "De Novo": 0, "PMA": 0 }, "1998": { "510(k)": 0, "De Novo": 0, "PMA": 2 }, "2001": { "510(k)": 1, "De Novo": 0, "PMA": 1 }, "2002": { "510(k)": 0, "De Novo": 0, "PMA": 1 }, "2004": { "510(k)": 1, "De Novo": 0, "PMA": 0 }, "2005": { "510(k)": 1, "De Novo": 0, "PMA": 0 }, "2006": { "510(k)": 0, "De Novo": 0, "PMA": 1 }, "2008": { "510(k)": 5, "De Novo": 0, "PMA": 0 }, "2010": { "510(k)": 2, "De Novo": 0, "PMA": 0 }, "2011": { "510(k)": 2, "De Novo": 0, "PMA": 1 }, "2012": { "510(k)": 4, "De Novo": 0, "PMA": 1 }, "2013": { "510(k)": 3, "De Novo": 1, "PMA": 0 }, "2014": { "510(k)": 5, "De Novo": 1, "PMA": 0 }, "2015": { "510(k)": 6, "De Novo": 0, "PMA": 0 }, "2016": { "510(k)": 17, "De Novo": 0, "PMA": 1 }, "2017": { "510(k)": 23, "De Novo": 2, "PMA": 2 }, "2018": { "510(k)": 58, "De Novo": 7, "PMA": 0 }, "2019": { "510(k)": 80, "De Novo": 0, "PMA": 0 }, "2020": { "510(k)": 113, "De Novo": 1, "PMA": 0 }, "2021": { "510(k)": 122, "De Novo": 6, "PMA": 1 }, "2022": { "510(k)": 160, "De Novo": 1, "PMA": 1 }, "2023": { "510(k)": 219, "De Novo": 6, "PMA": 1 }, "2024": { "510(k)": 225, "De Novo": 9, "PMA": 1 }, "2025": { "510(k)": 329, "De Novo": 2, "PMA": 4 }, "2026": { "510(k)": 176, "De Novo": 4, "PMA": 1 } } }, "devices": [ { "decision_date": "2026-06-29", "submission_number": "K260667", "pathway": "510(k)", "device": "Alturion Series Diagnostic Ultrasound System", "company": "Philips Ultrasound, LLC", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260667", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-29", "submission_number": "K253969", "pathway": "510(k)", "device": "ADAS 3D", "company": "Adas3D Medical S.L.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253969", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-29", "submission_number": "K253628", "pathway": "510(k)", "device": "Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)", "company": "Agada Medical, Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253628", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-27", "submission_number": "K253390", "pathway": "510(k)", "device": "SOMNUM (SOMNUM)", "company": "Honeynaps Co., Ltd.", "panel_lead": "Neurology", "primary_product_code": "OLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253390", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-26", "submission_number": "K260714", "pathway": "510(k)", "device": "MammoScreen® (5)", "company": "Therapixel", "panel_lead": "Radiology", "primary_product_code": "QDQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260714", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-25", "submission_number": "K253786", "pathway": "510(k)", "device": "syngo.CT Coronary Cockpit", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253786", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-24", "submission_number": "K253560", "pathway": "510(k)", "device": "Enhanced Boundary for PCCT", "company": "Ge Medical Systems, LLC", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253560", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-22", "submission_number": "K260316", "pathway": "510(k)", "device": "CMN Capillary Function with Oncology Virtual Expert", "company": "Cercare Medical A/S", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260316", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-22", "submission_number": "K253148", "pathway": "510(k)", "device": "RX-1 Sleep", "company": "Vivaquant, Inc. Dba Rhythm Express", "panel_lead": "Anesthesiology", "primary_product_code": "MNR", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253148", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-18", "submission_number": "K261713", "pathway": "510(k)", "device": "Synapse PACS (7.6.0)", "company": "FUJIFILM Healthcare Americas Corporation", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261713", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-18", "submission_number": "K260729", "pathway": "510(k)", "device": "Vascular Assist Occlusion Triage (VAOT) (v1.0)", "company": "GuideAI Health", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260729", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-18", "submission_number": "K260190", "pathway": "510(k)", "device": "ARTHUR", "company": "ROPCA ApS", "panel_lead": "Radiology", "primary_product_code": "IYO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260190", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-18", "submission_number": "K253050", "pathway": "510(k)", "device": "RadOncAI", "company": "Informai", "panel_lead": "Radiology", "primary_product_code": "MUJ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253050", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-16", "submission_number": "K260844", "pathway": "510(k)", "device": "ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260844", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-15", "submission_number": "K260300", "pathway": "510(k)", "device": "WatchMate Software", "company": "Anumana, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260300", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-15", "submission_number": "K253825", "pathway": "510(k)", "device": "Saige-Dx", "company": "DeepHealth, Inc.", "panel_lead": "Radiology", "primary_product_code": "QDQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253825", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-15", "submission_number": "K253690", "pathway": "510(k)", "device": "LungMaps", "company": "Siemens Healthineers AG", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253690", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-15", "submission_number": "K253172", "pathway": "510(k)", "device": "MediAI-OA", "company": "Crescom Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253172", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-12", "submission_number": "K260406", "pathway": "510(k)", "device": "Brainomix 360 Hyperdensity", "company": "Brainomix Limited", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260406", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-11", "submission_number": "K260322", "pathway": "510(k)", "device": "Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)", "company": "Mighty Oak Medical", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260322", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-10", "submission_number": "K253192", "pathway": "510(k)", "device": "DeepXray Spina", "company": "Alpha Intelligence Manifolds, Inc.", "panel_lead": "Radiology", "primary_product_code": "SAO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253192", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-08", "submission_number": "K260332", "pathway": "510(k)", "device": "EchoNext", "company": "Pathwai, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "QXO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260332", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-04", "submission_number": "K261519", "pathway": "510(k)", "device": "Sonio Suspect", "company": "Sonio", "panel_lead": "Radiology", "primary_product_code": "POK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261519", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-04", "submission_number": "K260497", "pathway": "510(k)", "device": "DEEPVESSEL Plaque", "company": "Keya Medical Technology Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260497", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-04", "submission_number": "K253984", "pathway": "510(k)", "device": "Instrument Exit Point on Touch Surgery™ Aide", "company": "Covidien, LLC", "panel_lead": "Gastroenterology-Urology", "primary_product_code": "SFE", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253984", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-03", "submission_number": "K260780", "pathway": "510(k)", "device": "HeartFocus", "company": "Deski", "panel_lead": "Radiology", "primary_product_code": "QJU", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260780", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-03", "submission_number": "K260402", "pathway": "510(k)", "device": "MeRT System", "company": "Wave Neuroscience", "panel_lead": "Neurology", "primary_product_code": "SIG", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260402", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-06-02", "submission_number": "K252844", "pathway": "510(k)", "device": "Tyto Insights for Wheeze Detection (with PCCP)", "company": "Tyto Care , Ltd.", "panel_lead": "Anesthesiology", "primary_product_code": "PHZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252844", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-29", "submission_number": "K261369", "pathway": "510(k)", "device": "GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)", "company": "Cosmo Artificial Intelligence - Ai, Ltd.", "panel_lead": "Gastroenterology-Urology", "primary_product_code": "QNP", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261369", "tracker_id": "gi-genius", "family_evidence_grade": "A" }, { "decision_date": "2026-05-29", "submission_number": "K260077", "pathway": "510(k)", "device": "OrthoGrid Hip AI® 4.0", "company": "OrthoGrid Systems, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260077", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-29", "submission_number": "K252947", "pathway": "510(k)", "device": "HistoSonics® Planning Tool", "company": "HistoSonics, Inc.", "panel_lead": "Radiology", "primary_product_code": "QTZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252947", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-29", "submission_number": "K252859", "pathway": "510(k)", "device": "ZEUS Platform (FG0501US)", "company": "iRhythm Technologies, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "DQK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252859", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-28", "submission_number": "K261405", "pathway": "510(k)", "device": "ANDI 2.2", "company": "Imeka Solutions, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261405", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-27", "submission_number": "K260680", "pathway": "510(k)", "device": "EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems", "company": "Philips Ultrasound, LLC", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260680", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-27", "submission_number": "K260123", "pathway": "510(k)", "device": "EPIQ Series Diagnostic Ultrasound System", "company": "Philips Ultrasound, LLC", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260123", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-27", "submission_number": "K254075", "pathway": "510(k)", "device": "Synapse Lung Nodule AI", "company": "Fujifilm Corporation", "panel_lead": "Radiology", "primary_product_code": "OEB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254075", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-22", "submission_number": "K260324", "pathway": "510(k)", "device": "Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning", "company": "Canon Medical Informatics, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260324", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-22", "submission_number": "K260113", "pathway": "510(k)", "device": "uMR Astra", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260113", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-22", "submission_number": "DEN250057", "pathway": "De Novo", "device": "PCWP Analysis Software", "company": "Cardiosense, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "SIF", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250057", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-21", "submission_number": "K260234", "pathway": "510(k)", "device": "MSK Go", "company": "Smart Alfa Teknoloji San. Ve Tic. A.S.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260234", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-21", "submission_number": "K254131", "pathway": "510(k)", "device": "BAC", "company": "DeepHealth, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254131", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-21", "submission_number": "K253720", "pathway": "510(k)", "device": "uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite", "company": "Wuhan United Imaging Healthcare Co.,Ltd", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253720", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-21", "submission_number": "DEN250028", "pathway": "De Novo", "device": "DeepView AI® System", "company": "spectralmd, inc.", "panel_lead": "General and Plastic Surgery", "primary_product_code": "SHY", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250028", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-20", "submission_number": "K253596", "pathway": "510(k)", "device": "Aquilion ONE (TSX-308A/TSX-306A) V2.0", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253596", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-15", "submission_number": "K261289", "pathway": "510(k)", "device": "UNiD™ Spine Analyzer (SW3002)", "company": "Medicrea International S.A.S. (Medtronic)", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261289", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-15", "submission_number": "K261273", "pathway": "510(k)", "device": "Neurophet AQUA", "company": "Neurophet., Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261273", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-15", "submission_number": "K254120", "pathway": "510(k)", "device": "SubtleHD-CT (1.x)", "company": "Subtle Medical, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254120", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-15", "submission_number": "K253716", "pathway": "510(k)", "device": "uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super", "company": "Wuhan United Imaging Healthcare Co.,Ltd", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253716", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-15", "submission_number": "K252563", "pathway": "510(k)", "device": "Neurophet SCALE PET", "company": "Neurophet., Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252563", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-15", "submission_number": "K250781", "pathway": "510(k)", "device": "Embryo Predict", "company": "Alife Health", "panel_lead": "Obstetrics and Gynecology", "primary_product_code": "PBH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250781", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-14", "submission_number": "K261317", "pathway": "510(k)", "device": "BriefCase-Triage", "company": "Aidoc Medical , Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261317", "tracker_id": "aidoc-briefcase-ich", "family_evidence_grade": "C" }, { "decision_date": "2026-05-14", "submission_number": "K254013", "pathway": "510(k)", "device": "SubtleHD-PET (1.x)", "company": "Subtle Medical, Inc.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254013", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-13", "submission_number": "K260032", "pathway": "510(k)", "device": "Morph", "company": "BeauBrain Healthcare, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260032", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-12", "submission_number": "K260378", "pathway": "510(k)", "device": "Rayvolve", "company": "AZmed", "panel_lead": "Radiology", "primary_product_code": "QBS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260378", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-11", "submission_number": "K252953", "pathway": "510(k)", "device": "Velmeni for Dentists (V4D) Endo-Perio", "company": "Velmeni, Inc.", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252953", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-08", "submission_number": "K260419", "pathway": "510(k)", "device": "LingOral Dental Design System", "company": "Hangzhou ChohoTech Co., Ltd.", "panel_lead": "Dental", "primary_product_code": "PNN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260419", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-07", "submission_number": "K253992", "pathway": "510(k)", "device": "Veritas Reverse Total Shoulder System", "company": "Restor3D", "panel_lead": "Orthopedic", "primary_product_code": "PHX", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253992", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-05", "submission_number": "K252558", "pathway": "510(k)", "device": "Lumify Diagnostic Ultrasound System", "company": "Philips Ultrasound, LLC", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252558", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-04", "submission_number": "K254115", "pathway": "510(k)", "device": "ArteraAI Breast", "company": "Artera, Inc.", "panel_lead": "Pathology", "primary_product_code": "SHW", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254115", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-04", "submission_number": "K252954", "pathway": "510(k)", "device": "MammoSightAI", "company": "Neurocareai, Inc. (Dba Savelife.Ai)", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252954", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-05-01", "submission_number": "K253030", "pathway": "510(k)", "device": "Capnostream™35 Portable Respiratory Monitor (PM35MN)", "company": "Covidien, LLC", "panel_lead": "Anesthesiology", "primary_product_code": "CCK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253030", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-30", "submission_number": "K254189", "pathway": "510(k)", "device": "Synapse 3D Base Tools (V7.2)", "company": "Fujifilm Corporation", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254189", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-30", "submission_number": "K252503", "pathway": "510(k)", "device": "Intelligent NR", "company": "Canon, Inc.", "panel_lead": "Radiology", "primary_product_code": "OWB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252503", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-30", "submission_number": "K250680", "pathway": "510(k)", "device": "Bayesian Health Sepsis Flagging Device", "company": "Bayesian Health, Inc.", "panel_lead": "General Hospital", "primary_product_code": "SAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250680", "tracker_id": "bayesian-trews", "family_evidence_grade": "A" }, { "decision_date": "2026-04-29", "submission_number": "K254184", "pathway": "510(k)", "device": "syngo Application Software", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254184", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-29", "submission_number": "K253682", "pathway": "510(k)", "device": "DeepHealth ProstateAI", "company": "Quantib B.V.", "panel_lead": "Radiology", "primary_product_code": "QDQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253682", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-27", "submission_number": "K252628", "pathway": "510(k)", "device": "CASSIE", "company": "Wesper, Inc.", "panel_lead": "Anesthesiology", "primary_product_code": "MNR", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252628", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-24", "submission_number": "K253459", "pathway": "510(k)", "device": "OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)", "company": "ABBOTT MEDICAL", "panel_lead": "Radiology", "primary_product_code": "NQQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253459", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-23", "submission_number": "K260785", "pathway": "510(k)", "device": "DS Core CBCT Anatomy", "company": "Dentsply Sirona", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260785", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-23", "submission_number": "K260320", "pathway": "510(k)", "device": "Lunit INSIGHT MMG (v1.1.10)", "company": "Lunit, Inc.", "panel_lead": "Radiology", "primary_product_code": "QDQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260320", "tracker_id": "lunit-insight-mmg", "family_evidence_grade": "B" }, { "decision_date": "2026-04-22", "submission_number": "K253256", "pathway": "510(k)", "device": "myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)", "company": "Otto Bock Healthcare Products GmbH", "panel_lead": "Neurology", "primary_product_code": "GXY", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253256", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-22", "submission_number": "K253163", "pathway": "510(k)", "device": "EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)", "company": "Ever Fortune.Ai, Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253163", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-22", "submission_number": "K253077", "pathway": "510(k)", "device": "uOmnispace.MR", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253077", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-20", "submission_number": "K252332", "pathway": "510(k)", "device": "Folliscan", "company": "Mim Fertility", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252332", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-17", "submission_number": "K252945", "pathway": "510(k)", "device": "Novasight Hybrid System", "company": "Conavi Medical, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "OBJ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252945", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-17", "submission_number": "K252237", "pathway": "510(k)", "device": "EdgeFlow UW20", "company": "Edgecare, Inc.", "panel_lead": "Radiology", "primary_product_code": "IYO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252237", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-14", "submission_number": "K253502", "pathway": "510(k)", "device": "Critical Care Suite with Enteric Tube Positioning AI Algorithm", "company": "Ge Medical Systems, LLC", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253502", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-10", "submission_number": "K260082", "pathway": "510(k)", "device": "TRIOS Dx (R1)", "company": "3Shape TRIOS A/S", "panel_lead": "Dental", "primary_product_code": "SHQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260082", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-10", "submission_number": "K253930", "pathway": "510(k)", "device": "Overjet Iris Intelligent Imaging System", "company": "Overjet, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253930", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-10", "submission_number": "K253689", "pathway": "510(k)", "device": "syngo Dynamics (VA41F)", "company": "Siemens Healthcare GmbH", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253689", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-10", "submission_number": "K252708", "pathway": "510(k)", "device": "Relu Cloud", "company": "Relu BV", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252708", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-10", "submission_number": "K252548", "pathway": "510(k)", "device": "AI-Rad Companion Organs RT", "company": "Siemens Healthcare GmbH", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252548", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-10", "submission_number": "K252190", "pathway": "510(k)", "device": "DeepBT Detector-Plus", "company": "Aitewan Biomedical Technology, Inc.", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252190", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-09", "submission_number": "K252228", "pathway": "510(k)", "device": "Seaman Pro/Seaman", "company": "Checkcells, Inc.", "panel_lead": "Hematology", "primary_product_code": "POV", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252228", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-07", "submission_number": "K253801", "pathway": "510(k)", "device": "ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)", "company": "Anumana, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "SHP", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253801", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-06", "submission_number": "K253288", "pathway": "510(k)", "device": "6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)", "company": "Esaote, S.p.A.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253288", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-03", "submission_number": "K260724", "pathway": "510(k)", "device": "MAGENTIQ-COLO (ME-APDS)", "company": "Magentiq Eye, Ltd.", "panel_lead": "Gastroenterology-Urology", "primary_product_code": "QNP", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260724", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-03", "submission_number": "K260524", "pathway": "510(k)", "device": "uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "KPS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260524", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-04-01", "submission_number": "K254015", "pathway": "510(k)", "device": "CoLumbo C-Spine", "company": "Smart Soft Healthcare AD", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254015", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-30", "submission_number": "K254207", "pathway": "510(k)", "device": "AiORTA - Plan v2.0", "company": "ViTAA Medical Solutions, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254207", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-28", "submission_number": "K252360", "pathway": "510(k)", "device": "ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)", "company": "Anumana, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "SAT", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252360", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-27", "submission_number": "K260746", "pathway": "510(k)", "device": "S-scan Open (100001800)", "company": "Esaote, S.p.A.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260746", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-27", "submission_number": "K254161", "pathway": "510(k)", "device": "Automated Aortic Stenosis Software (AutoAS)", "company": "GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC", "panel_lead": "Radiology", "primary_product_code": "POK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254161", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-27", "submission_number": "K253649", "pathway": "510(k)", "device": "Spectral CT Verida Family", "company": "Philips Medical Systems Technologies , Ltd.", "panel_lead": "Radiology", 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"tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-27", "submission_number": "K253270", "pathway": "510(k)", "device": "Contour ProtégéAI+", "company": "Mim Software, Inc.", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253270", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-27", "submission_number": "K252148", "pathway": "510(k)", "device": "Butterfly Gestational Age Tool", "company": "Butterfly Network, Inc.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252148", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-26", "submission_number": "K253796", "pathway": "510(k)", "device": "Lunit INSIGHT DBT (V1.2)", "company": "Lunit, Inc.", "panel_lead": "Radiology", "primary_product_code": "QDQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253796", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-26", "submission_number": "K253775", "pathway": "510(k)", "device": "SwiftMR", "company": "Airs Medical, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253775", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-26", "submission_number": "K253379", "pathway": "510(k)", "device": "Stealth AXiS Cranial clinical application", "company": "Medtronic Navigation, Inc.", "panel_lead": "Neurology", "primary_product_code": "HAW", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253379", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-24", "submission_number": "K260673", "pathway": "510(k)", "device": "LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260673", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-24", "submission_number": "K252421", "pathway": "510(k)", "device": "JLK-NCCT", "company": "JLK, Inc.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252421", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-24", "submission_number": "K252099", "pathway": "510(k)", "device": "Trinias", "company": "Shimadzu Corporation", "panel_lead": "Radiology", "primary_product_code": "OWB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252099", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-23", "submission_number": "K253686", "pathway": "510(k)", "device": "True Definition DL", "company": "Ge Healthcare Japan Corporation", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253686", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-23", "submission_number": "K252992", "pathway": "510(k)", "device": "CT Rembra RT; CT Areta RT; CT Rembra", "company": "Philips Healthcare (Suzhou) Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252992", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-20", "submission_number": "K253574", "pathway": "510(k)", "device": "SOMATOM X.cite; SOMATOM X.ceed", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253574", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-20", "submission_number": "K253520", "pathway": "510(k)", "device": "Photonova Spectra, Photonova Spectra Select", "company": "Ge Medical Systems, LLC", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253520", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-19", "submission_number": "K260509", "pathway": "510(k)", "device": "AutoContour (RADAC V5)", "company": "Radformation, Inc.", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260509", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-18", "submission_number": "K252304", "pathway": "510(k)", "device": "syngo.via RT Image Suite VC10", "company": "Varian Medical Systems, Inc.", "panel_lead": "Radiology", "primary_product_code": "MUJ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252304", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-17", "submission_number": "K253614", "pathway": "510(k)", "device": "EchoNavigator R5.0", "company": "Philips Medical Systems Nederland B.V.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253614", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-17", "submission_number": "DEN250014", "pathway": "De Novo", "device": "Tyto Insights for Eardrum Bulging Detection", "company": "Tyto Care , Ltd.", "panel_lead": "Ear Nose & 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"pathway": "510(k)", "device": "SurgiCount+ System", "company": "Stryker Instruments", "panel_lead": "General Hospital", "primary_product_code": "PBZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252282", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-13", "submission_number": "K260078", "pathway": "510(k)", "device": "Aquilion ServeSP (TSX-307B) V2.0", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260078", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-13", "submission_number": "K252261", "pathway": "510(k)", "device": "InferCare RECIST", "company": "Beijing Infervision Healthcare Medical Technology Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252261", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-12", "submission_number": "K252089", "pathway": "510(k)", "device": "Tyto Stethoscope (G3)", "company": "Tyto Care , Ltd.", "panel_lead": "Cardiovascular", "primary_product_code": "DQD", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252089", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-12", "submission_number": "K250655", "pathway": "510(k)", "device": "Deep Capsule® (Deep Capsule US)", "company": "Digestaid - Artificial Intelligence Development SA", "panel_lead": "Gastroenterology-Urology", "primary_product_code": "QZF", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250655", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-10", "submission_number": "K253584", "pathway": "510(k)", "device": "Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "OWB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253584", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-09", "submission_number": "K253413", "pathway": "510(k)", "device": "LiverMultiScan (v6.0)", "company": "Perspectum, Ltd.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253413", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-08", "submission_number": "K253668", "pathway": "510(k)", "device": "Onera SleepMap (SLEEPMAP)", "company": "Onera B.V.", "panel_lead": "Neurology", "primary_product_code": "OLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253668", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-06", "submission_number": "K260167", "pathway": "510(k)", "device": "Bunkerhill Contrast AVC", "company": "BunkerHill Health", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260167", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-06", "submission_number": "K260166", "pathway": "510(k)", "device": "Bunkerhill Contrast CAC", "company": "BunkerHill Health", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260166", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-06", "submission_number": "K253551", "pathway": "510(k)", "device": "VELYS™ Hip Navigation", "company": "Depuy Ireland UC", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253551", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-05", "submission_number": "K260169", "pathway": "510(k)", "device": "AV Cardiac CT", "company": "Philips Medical Systems Nederland B.V.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260169", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-05", "submission_number": "K253442", "pathway": "510(k)", "device": "EarliPoint Assessment", "company": "Earlitec Diagnostics", "panel_lead": "Neurology", "primary_product_code": "QPF", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253442", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-05", "submission_number": "K252538", "pathway": "510(k)", "device": "CEPHX3D", "company": "Orca Dental AI , Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252538", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-05", "submission_number": "K251901", "pathway": "510(k)", "device": "Magnifico Open (100009900)", "company": "Esaote, S.p.A.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251901", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-04", "submission_number": "K253898", "pathway": "510(k)", "device": "QT Scanner 2000 Model A", "company": "QT Imaging Holdings, Inc.", "panel_lead": "Radiology", "primary_product_code": "IYO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253898", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-03", "submission_number": "P250008", "pathway": "PMA", "device": "Claire™ OCT System", "company": "Perimeter Medical Imaging Ai, Inc.", "panel_lead": "General and Plastic Surgery", "primary_product_code": "SHH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250008", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-03", "submission_number": "K253818", "pathway": "510(k)", "device": "Annalise Enterprise", "company": "Harrison-AI Medical Pty, Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253818", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-03-02", "submission_number": "K253593", "pathway": "510(k)", "device": "Clarius Ejection Fraction AI", "company": "Clarius Mobile Health Corp.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253593", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-27", "submission_number": "K253535", "pathway": "510(k)", "device": "Ligence Heart", "company": "Ligence Uab", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253535", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-26", "submission_number": "K253578", "pathway": "510(k)", "device": "BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device", "company": "Aidoc Medical , Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253578", "tracker_id": "aidoc-care", "family_evidence_grade": "D" }, { "decision_date": "2026-02-24", "submission_number": "K260217", "pathway": "510(k)", "device": "AI Platform 2.2 (AIP002)", "company": "Exo Imaging", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260217", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-23", "submission_number": "K260265", "pathway": "510(k)", "device": "MAGNETOM Flow.Ace; MAGNETOM Flow.Plus", "company": "Siemens Shenzhen Magnetic Resonance , Ltd.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260265", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-23", "submission_number": "K253648", "pathway": "510(k)", "device": "Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades", "company": "Philips Medical Systems Nederland B.V.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253648", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-20", "submission_number": "K252972", "pathway": "510(k)", "device": "CARTO™ 3 EP Navigation System V8.4", "company": "Biosense Webster, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "DQK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252972", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-20", "submission_number": "K252500", "pathway": "510(k)", "device": "CARA System", "company": "Cara Medical, Ltd.", "panel_lead": "Radiology", "primary_product_code": "OWB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252500", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-19", "submission_number": "K252002", "pathway": "510(k)", "device": "Monaco RTP System (6.3)", "company": "Elekta Solutions AB", "panel_lead": "Radiology", "primary_product_code": "MUJ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252002", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-13", "submission_number": "K253564", "pathway": "510(k)", "device": "uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "KPS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253564", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-13", "submission_number": "K250233", "pathway": "510(k)", "device": "PreemptiveAI Clinical SDK", "company": "Measure Labs, Inc. (Dba Preemptiveai, Inc.)", "panel_lead": "Cardiovascular", "primary_product_code": "DXH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250233", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-12", "submission_number": "K253381", "pathway": "510(k)", "device": "Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application", "company": "Medtronic Navigation, Inc.", "panel_lead": "Neurology", "primary_product_code": "OLO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253381", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-11", "submission_number": "K252084", "pathway": "510(k)", "device": "AI4CMR v2.0", "company": "Ai4medimaging Medical Solutions S.A.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252084", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-11", "submission_number": "DEN250007", "pathway": "De Novo", "device": "Delivery Date AI", "company": "Ultrasound AI", "panel_lead": "Radiology", "primary_product_code": "SHE", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250007", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-10", "submission_number": "K254016", "pathway": "510(k)", "device": "MI View&GO", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254016", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-06", "submission_number": "K253780", "pathway": "510(k)", "device": "SIGNA™ Bolt", "company": "Ge Medical Systems, LLC", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253780", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-06", "submission_number": "K252076", "pathway": "510(k)", "device": "Kneevoice Cartilage Evaluation System (750-3600-001)", "company": "Kneevoice, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "DQD", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252076", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-06", "submission_number": "K251474", "pathway": "510(k)", "device": "Median LCS (internal name) / eyonis LCS (trade name) (1.0)", "company": "Median Technologies", "panel_lead": "Radiology", "primary_product_code": "QDQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251474", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-06", "submission_number": "K251218", "pathway": "510(k)", "device": "SafeBeat Rx App", "company": "SafeBeat Rx, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "DQK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251218", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-06", "submission_number": "K243348", "pathway": "510(k)", "device": "Athelas Home", "company": "Athelas, Inc.", "panel_lead": "Hematology", "primary_product_code": "GKZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243348", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-05", "submission_number": "K253779", "pathway": "510(k)", "device": "SIGNA™ Sprint Select", "company": "Ge Medical Systems, LLC", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253779", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-04", "submission_number": "K260104", "pathway": "510(k)", "device": "Signature™ ONE System", "company": "Orthosoft Inc. (d/b/a) Zimmer CAS", "panel_lead": "Orthopedic", "primary_product_code": "QHE", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260104", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-02-02", "submission_number": "K251200", "pathway": "510(k)", "device": "Vital Signs", "company": "Oxehealth Limited", "panel_lead": "Cardiovascular", "primary_product_code": "QME", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251200", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-30", "submission_number": "K251769", "pathway": "510(k)", "device": "RevealAI-Lung", "company": "Precision Medical Ventures, Inc. Dba Revealdx", "panel_lead": "Radiology", "primary_product_code": "POK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251769", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-29", "submission_number": "K252496", "pathway": "510(k)", "device": "Neurophet AQUA AD Plus", "company": "Neurophet., Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252496", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-29", "submission_number": "K252091", "pathway": "510(k)", "device": "Surgical Reality Viewer", "company": "Medicalvr B.V.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252091", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-28", "submission_number": "K251306", "pathway": "510(k)", "device": "Seg Pro V3 (RT-300)", "company": "Ever Fortune.Ai, Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251306", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-27", "submission_number": "K251195", "pathway": "510(k)", "device": "BriefCase-Triage", "company": "Aidoc Medical , Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251195", "tracker_id": "aidoc-briefcase-ich", "family_evidence_grade": "C" }, { "decision_date": "2026-01-23", "submission_number": "K251351", "pathway": "510(k)", "device": "AccuContour 4.0", "company": "Manteia Technologies Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251351", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-23", "submission_number": "K243349", "pathway": "510(k)", "device": "BodyGuardian Remote Monitoring System (BGRMS v3.0)", "company": "Boston Scientific Cardiac Diagnostic Technologies, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "DSI", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243349", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-22", "submission_number": "K253735", "pathway": "510(k)", "device": "AV Vascular", "company": "Philips Medical Systems Nederland B.V.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253735", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-22", "submission_number": "K253057", "pathway": "510(k)", "device": "AI-Rad Companion Brain MR", "company": "Siemens Healthcare GmbH", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253057", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-22", "submission_number": "K252984", "pathway": "510(k)", "device": "Perin Health System (PHD80060-2)", "company": "Perin Health Devices, LLC", "panel_lead": "Cardiovascular", "primary_product_code": "DRG", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252984", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-22", "submission_number": "K251511", "pathway": "510(k)", "device": "PhenoMATRIX", "company": "Copan Wasp Srl", "panel_lead": "Microbiology", "primary_product_code": "PPU", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251511", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-20", "submission_number": "K253173", "pathway": "510(k)", "device": "uCT 780 with uWS-CT-Dual Energy Analysis", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253173", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-16", "submission_number": "K252634", "pathway": "510(k)", "device": "Imagine® Enterprise Suite", "company": "Softlink International Private Limited", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252634", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-16", "submission_number": "K251934", "pathway": "510(k)", "device": "qXR-Detect", "company": "Qure.Ai Technologies", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251934", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-15", "submission_number": "K253023", "pathway": "510(k)", "device": "BIOGRAPH One", "company": "Siemens Healthineers AG", "panel_lead": "Radiology", "primary_product_code": "OUO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253023", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-15", "submission_number": "K252934", "pathway": "510(k)", "device": "Diagnocat", "company": "DGNCT, LLC", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252934", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-15", "submission_number": "K252188", "pathway": "510(k)", "device": "EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)", "company": "Elekta Solutions AB", "panel_lead": "Radiology", "primary_product_code": "IYE", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252188", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-13", "submission_number": "K254001", "pathway": "510(k)", "device": "VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)", "company": "Spectrum Dynamics Medical, Ltd.", "panel_lead": "Radiology", "primary_product_code": "KPS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254001", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-12", "submission_number": "K251558", "pathway": "510(k)", "device": "Precision AI Surgical Planning System (PAI-SPS)", "company": "Precision AI Pty, Ltd.", "panel_lead": "Orthopedic", "primary_product_code": "QHE", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251558", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-11", "submission_number": "K252842", "pathway": "510(k)", "device": "SafeOp 3: Neural Informatix System", "company": "Alphatec Spine, Inc.", "panel_lead": "Neurology", "primary_product_code": "GWF", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252842", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-09", "submission_number": "K252589", "pathway": "510(k)", "device": "Corvair Monza", "company": "AliveCor, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "MHX", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252589", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-08", "submission_number": "K253370", "pathway": "510(k)", "device": "LOGIQ Totus", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253370", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-07", "submission_number": "K253366", "pathway": "510(k)", "device": "LOGIQ Fortis", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253366", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-07", "submission_number": "K253009", "pathway": "510(k)", "device": "DS Core Detect", "company": "Dentsply Sirona, Inc.", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253009", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2026-01-07", "submission_number": "K252970", "pathway": "510(k)", "device": "BriefCase-Triage: CARE Multi-triage CT Body", "company": "Aidoc Medical , Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252970", "tracker_id": "aidoc-care", "family_evidence_grade": "D" }, { "decision_date": "2026-01-05", "submission_number": "K252018", "pathway": "510(k)", "device": "HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System", "company": "Samsung Medison Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252018", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-30", "submission_number": "K253532", "pathway": "510(k)", "device": "TruSPECT Processing Station", "company": "Spectrum Dynamics Medical, Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253532", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-23", "submission_number": "K253091", "pathway": "510(k)", "device": "ART-Plan+ (v3.1.0)", "company": "Therapanacea Sas", "panel_lead": "Radiology", "primary_product_code": "MUJ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253091", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-23", "submission_number": "K252379", "pathway": "510(k)", "device": "AIR Recon DL", "company": "Ge Medical Systems, LLC", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252379", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-22", "submission_number": "K253664", "pathway": "510(k)", "device": "SKOUT system", "company": "Iterative Health", "panel_lead": "Gastroenterology-Urology", "primary_product_code": "QNP", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253664", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-22", "submission_number": "K252856", "pathway": "510(k)", "device": "PeekMed web", "company": "Peek Health, S.A.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252856", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-22", "submission_number": "K252557", "pathway": "510(k)", "device": "Lumify Diagnostic Ultrasound System", "company": "Philips Ultrasound, LLC", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252557", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-22", "submission_number": "K250959", "pathway": "510(k)", "device": "BioticsAI", "company": "Bioticsai, Inc.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250959", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-19", "submission_number": "K252838", "pathway": "510(k)", "device": "MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise", "company": "Siemens Healthcare GmbH", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252838", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-19", "submission_number": "K252670", "pathway": "510(k)", "device": "Alzevita", "company": "TOPIA MEDTECH LIMITED", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252670", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-19", "submission_number": "K252284", "pathway": "510(k)", "device": "eMurmur Heart AI", "company": "Csd Labs", "panel_lead": "Cardiovascular", "primary_product_code": "DQD", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252284", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-19", "submission_number": "K252029", "pathway": "510(k)", "device": "AI-CVD", "company": "HeartLung Corporation", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252029", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-18", "submission_number": "K253516", "pathway": "510(k)", "device": "Assert-IQ (DM5100)", "company": "Abbott Medical", "panel_lead": "Cardiovascular", "primary_product_code": "MXD", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253516", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-18", "submission_number": "K252235", "pathway": "510(k)", "device": "PVAD IQ Software", "company": "Ultrasight , Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252235", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-18", "submission_number": "K250914", "pathway": "510(k)", "device": "MediAI-BA", "company": "Crescom Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250914", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-17", "submission_number": "K252922", "pathway": "510(k)", "device": "Neosoma Brain Mets", "company": "Neosoma, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252922", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-17", "submission_number": "K251416", "pathway": "510(k)", "device": "UltraSight Guidance", "company": "Ultrasight , Ltd.", "panel_lead": "Radiology", "primary_product_code": "QJU", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251416", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-16", "submission_number": "K252204", "pathway": "510(k)", "device": "prolaio eVO2peak Module (Version 1.0)", "company": "Prolaio, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "PPW", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252204", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-16", "submission_number": "K251763", "pathway": "510(k)", "device": "IRISeg", "company": "Intuitive Surgical, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251763", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-12", "submission_number": "K253489", "pathway": "510(k)", "device": "Swoop® Portable MR Imaging® System", "company": "Hyperfine, Inc.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253489", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-11", "submission_number": "K253141", "pathway": "510(k)", "device": "DeepRhythmAI", "company": "Medicalgorithmics S.A.", "panel_lead": "Cardiovascular", "primary_product_code": "DQK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253141", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-11", "submission_number": "K252482", "pathway": "510(k)", "device": "CogNet AI-MT+", "company": "Medcognetics, Inc.", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252482", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-10", "submission_number": "K252497", "pathway": "510(k)", "device": "SANSA HSAT", "company": "Huxley Medical", "panel_lead": "Anesthesiology", "primary_product_code": "MNR", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252497", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-09", "submission_number": "K243449", "pathway": "510(k)", "device": "INFINITT DPS", "company": "Infinitt Healthcare Co., Ltd.", "panel_lead": "Pathology", "primary_product_code": "QKQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243449", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-08", "submission_number": "K252294", "pathway": "510(k)", "device": "Fetal EchoScan (v1.2)", "company": "Brightheart", "panel_lead": "Radiology", "primary_product_code": "POK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252294", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-08", "submission_number": "K251936", "pathway": "510(k)", "device": "Ceribell Delirium Monitor System", "company": "Ceribell, Inc.", "panel_lead": "Neurology", "primary_product_code": "NCG", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251936", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-05", "submission_number": "K252504", "pathway": "510(k)", "device": "Gastric Alimetry", "company": "Alimetry , Ltd.", "panel_lead": "Gastroenterology-Urology", "primary_product_code": "MYE", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252504", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-05", "submission_number": "K251657", "pathway": "510(k)", "device": "Personalized Therapy Comfort Settings (PTCS)", "company": "ResMed Corp", "panel_lead": "Anesthesiology", "primary_product_code": "BZD", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251657", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-05", "submission_number": "K251514", "pathway": "510(k)", "device": "Overjet CBCT Assist", "company": "Overjet, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251514", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-05", "submission_number": "K250780", "pathway": "510(k)", "device": "ARTAssistant", "company": "Manteia Technologies Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250780", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-03", "submission_number": "K251203", "pathway": "510(k)", "device": "AVIEW Lung Nodule CAD", "company": "Coreline Soft Co.,Ltd", "panel_lead": "Radiology", "primary_product_code": "OEB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251203", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-02", "submission_number": "K252103", "pathway": "510(k)", "device": "Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)", "company": "Mighty Oak Medical", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252103", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-12-01", "submission_number": "K251370", "pathway": "510(k)", "device": "Cartesion Prime (PCD-1000A/3) V10.21", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "KPS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251370", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-28", "submission_number": "K252217", "pathway": "510(k)", "device": "CT VScore+", "company": "Canon Medical Informatics, Inc.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252217", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-26", "submission_number": "K253269", "pathway": "510(k)", "device": "OEC One CFD", "company": "Ge Hualun Medical Systems Co. , Ltd.", "panel_lead": "Radiology", "primary_product_code": "OXO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253269", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-25", "submission_number": "K253310", "pathway": "510(k)", "device": "7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)", "company": "Esaote, S.P.A.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253310", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-25", "submission_number": "K250694", "pathway": "510(k)", "device": "Scaida BrainCT-ICH (v1.0)", "company": "Mlhealth 360", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250694", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-25", "submission_number": "K250635", "pathway": "510(k)", "device": "FEops HEARTguide Simulation Application", "company": "Feops NV", "panel_lead": "Cardiovascular", "primary_product_code": "QQI", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250635", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-24", "submission_number": "K252366", "pathway": "510(k)", "device": "a2z-Unified-Triage", "company": "A2z Radiology Ai, Inc.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252366", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-24", "submission_number": "K252328", "pathway": "510(k)", "device": "Voluson Expert 18; Voluson Expert 20; Voluson Expert 22", "company": "Ge Medical Systems Ultrasound and Primary Care Diagnostics", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252328", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-21", "submission_number": "P130020/S005", "pathway": "PMA", "device": "Senographe Pristina 3D", "company": "GE Healthcare", "panel_lead": "Radiology", "primary_product_code": "OTE", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130020/S005", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-21", "submission_number": "K251506", "pathway": "510(k)", "device": "Nelli (Version 7.11)", "company": "Neuro Event Labs OY", "panel_lead": "Neurology", "primary_product_code": "POS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251506", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-21", "submission_number": "K251293", "pathway": "510(k)", "device": "CardioVision", "company": "Icardio.Ai", "panel_lead": "Cardiovascular", "primary_product_code": "QUO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251293", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-20", "submission_number": "K251822", "pathway": "510(k)", "device": "MAGNETOM Free.Max; MAGNETOM Free.Star", "company": "Siemens Shenzhen Magnetic Resonance , Ltd.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251822", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-17", "submission_number": "K252330", "pathway": "510(k)", "device": "DeepRESP", "company": "Nox Medical Ehf", "panel_lead": "Neurology", "primary_product_code": "OLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252330", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-17", "submission_number": "K252086", "pathway": "510(k)", "device": "DTX Studio Assist", "company": "Nobel Biocare C/O Medicim NV", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252086", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-14", "submission_number": "K251078", "pathway": "510(k)", "device": "AutoDensity", "company": "Eos Imaging", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251078", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-14", "submission_number": "K250525", "pathway": "510(k)", "device": "Second Opinion® Panoramic", "company": "Pearl, Inc.", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250525", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-12", "submission_number": "K252452", "pathway": "510(k)", "device": "PeekMed web", "company": "Peek Health, S.A.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252452", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-07", "submission_number": "K252041", "pathway": "510(k)", "device": "Fibresolve (with PCCP)", "company": "Imvaria, Inc.", "panel_lead": "Radiology", "primary_product_code": "QWO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252041", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-07", "submission_number": "K250264", "pathway": "510(k)", "device": "SugarBug (1.x)", "company": "Bench7, Inc.", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250264", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-06", "submission_number": "K253265", "pathway": "510(k)", "device": "BriefCase-Triage", "company": "Aidoc Medical , Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253265", "tracker_id": "aidoc-briefcase-ich", "family_evidence_grade": "C" }, { "decision_date": "2025-11-03", "submission_number": "K251532", "pathway": "510(k)", "device": "Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)", "company": "Mighty Oak Medical", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251532", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-11-03", "submission_number": "K250330", "pathway": "510(k)", "device": "3mensio Workstation", "company": "Pie Medical Imaging BV", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250330", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-10-31", "submission_number": "K252074", "pathway": "510(k)", "device": "Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252074", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-10-30", "submission_number": "K250337", "pathway": "510(k)", "device": "AiORTA - Plan", "company": "ViTAA Medical Solutions, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250337", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-10-29", "submission_number": "K251985", "pathway": "510(k)", "device": "LOGIQ E10", "company": "Ge Medical Systems Ultrasound and Primary Care Diagnostics", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251985", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-10-29", "submission_number": "K251963", "pathway": "510(k)", "device": "LOGIQ E10s", "company": "Ge Medical Systems Ultrasound and Primary Care Diagnostics", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251963", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-10-29", "submission_number": "K250882", "pathway": "510(k)", "device": "SANSA HSAT", "company": "Huxley Medical", "panel_lead": "Anesthesiology", "primary_product_code": "MNR", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250882", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-10-28", "submission_number": "P980016/S939", "pathway": "PMA", "device": "Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I", "company": "Medtronic Cardiac Rhythm Disease Management", "panel_lead": "Cardiovascular", "primary_product_code": "LWS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980016/S939", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-10-28", "submission_number": "P220012/S059", "pathway": "PMA", "device": "Aurora EV ICD (DVEA3E4)", "company": "Medtronic, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "LWS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220012/S059", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-10-27", "submission_number": "K251027", "pathway": "510(k)", "device": "cvi42 Coronary Plaque Software Application", "company": "Circle Cardiovascular Imaging, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251027", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-10-24", "submission_number": "K251059", "pathway": "510(k)", "device": "Syngo Carbon Clinicals (VA41)", "company": "Siemens Healthineers AG", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251059", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-10-23", "submission_number": "K250288", "pathway": "510(k)", "device": "TeraRecon Cardiovascular.Calcification.CT", "company": "Terarecon,Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250288", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-10-22", "submission_number": "K252298", "pathway": "510(k)", 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"2025-10-17", "submission_number": "K251355", "pathway": "510(k)", "device": "X1-FFR", "company": "Spectrawave, Inc.", "panel_lead": "Radiology", "primary_product_code": "QHA", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251355", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-10-10", "submission_number": "K251602", "pathway": "510(k)", "device": "Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "OWB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251602", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-10-10", "submission_number": "K251082", "pathway": "510(k)", "device": "HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)", "company": "Procept Biorobotics", "panel_lead": "General and Plastic 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"2025-10-06", "submission_number": "K252007", "pathway": "510(k)", "device": "BlineSlide", "company": "Deep Breathe, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252007", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-10-03", "submission_number": "K252178", "pathway": "510(k)", "device": "MAGENTIQ-COLO (ME-APDS)", "company": "Magentiq Eye, Ltd.", "panel_lead": "Gastroenterology-Urology", "primary_product_code": "QNP", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252178", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-10-03", "submission_number": "K251639", "pathway": "510(k)", "device": "xvision Spine system", "company": "Augmedics, Ltd.", "panel_lead": "Neurology", "primary_product_code": "SBF", "fda_url": 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"panel_lead": "Neurology", "primary_product_code": "SBF", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252054", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-29", "submission_number": "K250023", "pathway": "510(k)", "device": "SMART PCFD", "company": "Disior Ltd", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250023", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-26", "submission_number": "K252105", "pathway": "510(k)", "device": "Ligence Heart", "company": "Ligence, UAB", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252105", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-25", "submission_number": "K252371", "pathway": "510(k)", "device": "uMR 680", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252371", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-25", "submission_number": "K251527", "pathway": "510(k)", "device": "Brain WMH", "company": "Quantib BV", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251527", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-23", "submission_number": "K251987", "pathway": "510(k)", "device": "Rapid Aortic Measurements", "company": "iSchemaView, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251987", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-23", "submission_number": "K251483", "pathway": "510(k)", "device": "SwiftSight-Brain", "company": "AIRS Medical Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251483", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-19", "submission_number": "K251167", "pathway": "510(k)", "device": "uDR Aurora CX", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "KPR", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251167", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-19", "submission_number": "K251002", "pathway": "510(k)", "device": "Videa Dental AI", "company": "VideaHealth Inc.", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251002", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-19", "submission_number": "K250649", "pathway": "510(k)", "device": "Bunkerhill ECG-EF", "company": "BunkerHill Health", "panel_lead": "Cardiovascular", "primary_product_code": "QYE", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250649", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-18", "submission_number": "K250369", "pathway": "510(k)", "device": "Axial3D Insight", "company": "Axial Medical Printing Limited", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250369", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-17", "submission_number": "K251386", "pathway": "510(k)", "device": "ECHELON Synergy", "company": "Fujifilm Corporation", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251386", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-17", "submission_number": "K251221", "pathway": "510(k)", "device": "Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)", "company": "Abbott", "panel_lead": "Cardiovascular", "primary_product_code": "MXD", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251221", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-15", "submission_number": "K250237", "pathway": "510(k)", "device": "InferOperate Suite", "company": "Beijing Infervision Healthcare Medical Technology Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250237", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-12", "submission_number": "K252595", "pathway": "510(k)", "device": "Stethophone Pro", "company": "Sparrow Acoustics, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "DQD", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252595", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-12", "submission_number": "K252586", "pathway": "510(k)", "device": "CADDIE", "company": "Odin Medical Limited", "panel_lead": "Gastroenterology-Urology", "primary_product_code": "QNP", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252586", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-12", "submission_number": "K251518", "pathway": "510(k)", "device": "Volta AF-Xplorer II", "company": "Volta Medical", "panel_lead": "Cardiovascular", "primary_product_code": "DQK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251518", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-12", "submission_number": "K251368", "pathway": "510(k)", "device": "FETOLY", "company": "Diagnoly", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251368", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-11", "submission_number": "K251399", "pathway": "510(k)", "device": "SIGNA™ Sprint", "company": "GE Medical Systems, LLC", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251399", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-11", "submission_number": "K251316", "pathway": "510(k)", "device": "Mazor X System / Mazor X Stealth Edition", "company": "Mazor Robotics Ltd.", "panel_lead": "Neurology", "primary_product_code": "OLO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251316", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-11", "submission_number": "K250507", "pathway": "510(k)", "device": "Hypertension Notification Feature (HTNF)", "company": "Apple Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "SFR", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250507", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-10", "submission_number": "K244002", "pathway": "510(k)", "device": "AngioWaveNet", "company": "Angiowave Imaging, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K244002", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-09", "submission_number": "K251682", "pathway": "510(k)", "device": "MuscleView 2.0", "company": "Springbok, Inc. (dba Springbok Analytics)", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251682", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-09", "submission_number": "K251072", "pathway": "510(k)", "device": "Segmentron Viewer", "company": "DGNCT, LLC", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251072", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-08", "submission_number": "K251931", "pathway": "510(k)", "device": "BioTraceIO Vision (V1.7)", "company": "Techsomed Medical Technologies", "panel_lead": "Radiology", "primary_product_code": "QTZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251931", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-08", "submission_number": "K251610", "pathway": "510(k)", "device": "qER-CTA (v1.0)", "company": "Qure.ai Technologies", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251610", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-04", "submission_number": "K251656", "pathway": "510(k)", "device": "Careverse CoronaryDoc (Careverse CoronaryDoc)", "company": "Careverse Technology Pte. Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251656", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-04", "submission_number": "K251533", "pathway": "510(k)", "device": "Rapid Obstructive Hydrocephalus, Rapid OH", "company": "iSchemaView Inc.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251533", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-04", "submission_number": "K250064", "pathway": "510(k)", "device": "Dose+ (1.0)", "company": "Mvision AI Oy", "panel_lead": "Radiology", "primary_product_code": "MUJ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250064", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-03", "submission_number": "K252539", "pathway": "510(k)", "device": "Tempus Pixel", "company": "Arterys, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252539", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-02", "submission_number": "K251408", "pathway": "510(k)", "device": "OsteoSight™ Hip (v1)", "company": "Naitive Technologies Ltd", "panel_lead": "Radiology", "primary_product_code": "SAO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251408", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-09-02", "submission_number": "K250753", "pathway": "510(k)", "device": "VELMENI for DENTISTS (V4D)", "company": "Velmeni Inc.", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250753", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-29", "submission_number": "K251106", "pathway": "510(k)", "device": "Sonosite LX and Sonosite PX Ultrasound Systems", "company": "Fujifilm Sonosite Inc", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251106", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-29", "submission_number": "K250290", "pathway": "510(k)", "device": "SurgiTwin", "company": "Twinsight", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250290", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-29", "submission_number": "K250003", "pathway": "510(k)", "device": "GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)", "company": "Geneseeq Technology Inc.", "panel_lead": "Pathology", "primary_product_code": "PZM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250003", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-29", "submission_number": "K243859", "pathway": "510(k)", "device": "PRAEVAorta®2", "company": "Nurea", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243859", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-28", "submission_number": "K250788", "pathway": "510(k)", "device": "Definium Tempo Select", "company": "GE Hualun Medical Systems Co., Ltd", "panel_lead": "Radiology", "primary_product_code": "KPR", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250788", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-27", "submission_number": "K243687", "pathway": "510(k)", "device": "Vital Signs", "company": "Oxehealth Limited", "panel_lead": "Cardiovascular", "primary_product_code": "QME", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243687", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-26", "submission_number": "K251983", "pathway": "510(k)", "device": "Brainomix 360 Triage Stroke", "company": "Brainomix Limited", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251983", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-22", "submission_number": "K252362", "pathway": "510(k)", "device": "GBrain MRI", "company": "Galileo CDS, Inc", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252362", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-22", "submission_number": "K243685", "pathway": "510(k)", "device": "MammoScreen BD", "company": "Therapixel", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243685", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-21", "submission_number": "K251029", "pathway": "510(k)", "device": "Vista OS, Vista AI Scan, RTHawk", "company": "Vista AI, Inc.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251029", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-20", "submission_number": "K251837", "pathway": "510(k)", "device": "Salix Coronary Plaque (V1.0.0)", "company": "Artrya Limited", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251837", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-20", "submission_number": "K251590", "pathway": "510(k)", "device": "Methinks CTA Stroke", "company": "Methinks Software S.L.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251590", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-20", "submission_number": "K251481", "pathway": "510(k)", "device": "ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251481", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-15", "submission_number": "K251747", "pathway": "510(k)", "device": "VEA Align; spineEOS", "company": "EOS imaging", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251747", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-15", "submission_number": "K250818", "pathway": "510(k)", "device": "Nerveblox", "company": "Smart Alfa Teknoloji San. Ve Tic. A.S.", "panel_lead": "Anesthesiology", "primary_product_code": "QRG", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250818", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-15", "submission_number": "K243851", "pathway": "510(k)", "device": "CHLOE BLAST", "company": "Fairtility Ltd.", "panel_lead": "Obstetrics and Gynecology", "primary_product_code": "PBH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243851", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-12", "submission_number": "K251494", "pathway": "510(k)", "device": "Eko Foundation Analysis Software with Transformers (EFAST)", "company": "Eko Health, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "DQD", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251494", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-12", "submission_number": "K250755", "pathway": "510(k)", "device": "DS Core Diagnosis", "company": "Dentsply Sirona Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250755", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-11", "submission_number": "K251873", "pathway": "510(k)", "device": "Saige-Dx", "company": "DeepHealth, Inc.", "panel_lead": "Radiology", "primary_product_code": "QDQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251873", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-07", "submission_number": "K251629", "pathway": "510(k)", "device": "UNiD™ Spine Analyzer", "company": "Medicrea International S.A.S. (Medtronic)", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251629", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-06", "submission_number": "K250569", "pathway": "510(k)", "device": "Cardiologs Holter Platform", "company": "Philips France Commercial", "panel_lead": "Cardiovascular", "primary_product_code": "DPS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250569", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-05", "submission_number": "K250246", "pathway": "510(k)", "device": "uMR Jupiter", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250246", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-08-01", "submission_number": "K250941", "pathway": "510(k)", "device": "Revolution Vibe", "company": "GE Medical Systems, LLC", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250941", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-31", "submission_number": "K250738", "pathway": "510(k)", "device": "YSIO X.pree", "company": "Siemens Medical Solutions", "panel_lead": "Radiology", "primary_product_code": "KPR", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250738", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-31", "submission_number": "K243341", "pathway": "510(k)", "device": "Genius AI Detection 2.0", "company": "Hologic, Inc.", "panel_lead": "Radiology", "primary_product_code": "QDQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243341", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-31", "submission_number": "DEN240068", "pathway": "De Novo", "device": "ArteraAI Prostate", "company": "Artera Inc.", "panel_lead": "Pathology", "primary_product_code": "SFH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240068", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-30", "submission_number": "K243919", "pathway": "510(k)", "device": "Voxel Dosimetry (00859873006226)", "company": "Hermes Medical Solutions AB", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243919", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-28", "submission_number": "K250652", "pathway": "510(k)", "device": "ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)", "company": "Anumana, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "QYE", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250652", "tracker_id": "anumana-ecg-ai-lef", "family_evidence_grade": "A" }, { "decision_date": "2025-07-25", "submission_number": "K251322", "pathway": "510(k)", "device": "Venue; Venue Go; Venue Fit; Venue Sprint", "company": "GE Medical Systems Ultrasound and Primary care Diagnostics,", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251322", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-24", "submission_number": "K251455", "pathway": "510(k)", "device": "EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System", "company": "Philips Ultrasound LLC", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251455", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-23", "submission_number": "K243681", "pathway": "510(k)", "device": "Neuro Insight V1.0", "company": "Olea Medical S.A.S.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243681", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-22", "submission_number": "K250901", "pathway": "510(k)", "device": "Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250901", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-22", "submission_number": "K250686", "pathway": "510(k)", "device": "GyriCalc (Version 1.0.0)", "company": "NeuroSpectrum Insights Corp.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250686", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-18", "submission_number": "K250999", "pathway": "510(k)", "device": "V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System", "company": "Samsung Medison Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250999", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-18", "submission_number": "K250902", "pathway": "510(k)", "device": "HeartFlow Analysis", "company": "HeartFlow, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "PJA", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250902", "tracker_id": "heartflow-ffrct", "family_evidence_grade": "A" }, { "decision_date": "2025-07-17", "submission_number": "K251839", "pathway": "510(k)", "device": "uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "KPS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251839", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-17", "submission_number": "K243547", "pathway": "510(k)", "device": "uMR Ultra", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243547", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-16", "submission_number": "K251342", "pathway": "510(k)", "device": "EchoPAC Software Only / EchoPAC Plug-in", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251342", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-16", "submission_number": "K251151", "pathway": "510(k)", "device": "Rapid CTA 360", "company": "iSchemaView", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251151", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-16", "submission_number": "K243397", "pathway": "510(k)", "device": "uMR 680", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243397", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-15", "submission_number": "K250119", "pathway": "510(k)", "device": "Tempus ECG-Low EF", "company": "Tempus AI, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "QYE", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250119", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-14", "submission_number": "K251096", "pathway": "510(k)", "device": "PeekMed web", "company": "Peek Health, S.A.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251096", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-14", "submission_number": "K250660", "pathway": "510(k)", "device": "LUMINOS Q.namix T; LUMINOS Q.namix R", "company": "Siemens Medical Solutions", "panel_lead": "Radiology", "primary_product_code": "OWB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250660", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-10", "submission_number": "K251169", "pathway": "510(k)", "device": "Vivid Pioneer", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251169", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-08", "submission_number": "K251766", "pathway": "510(k)", "device": "TumorSight Viz", "company": "SimBioSys, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251766", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-07", "submission_number": "K243884", "pathway": "510(k)", "device": "TAVIPILOT", "company": "Caranx Medical", "panel_lead": "Radiology", "primary_product_code": "OWB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243884", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-07-03", "submission_number": "K251528", "pathway": "510(k)", "device": "syngo.via MI Workflows; 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}, { "decision_date": "2025-06-18", "submission_number": "K243672", "pathway": "510(k)", "device": "CardIQ Suite", "company": "GE Medical Systems SCS", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243672", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-06-18", "submission_number": "K243253", "pathway": "510(k)", "device": "6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)", "company": "Esaote S.p.A.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243253", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-06-17", "submission_number": "K250440", "pathway": "510(k)", "device": "RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT", "company": "Brainlab AG", "panel_lead": "Radiology", "primary_product_code": "MUJ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250440", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-06-16", "submission_number": "K250685", "pathway": "510(k)", "device": "Methinks NCCT Stroke", "company": "Methinks Software S.L.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250685", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-06-16", "submission_number": "K250443", "pathway": "510(k)", "device": "MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile", "company": "Siemens Healthcare GmbH", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250443", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-06-16", "submission_number": "K250436", "pathway": "510(k)", "device": "MAGNETOM Flow.Ace; MAGNETOM Flow.Plus", "company": "Siemens Shenzhen Magnetic Resonance , Ltd.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250436", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-06-15", "submission_number": "K240795", "pathway": "510(k)", "device": "Withings ECG App", "company": "Withings", "panel_lead": "Cardiovascular", "primary_product_code": "QDA", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240795", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-06-13", "submission_number": "K243633", "pathway": "510(k)", "device": "Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)", "company": "Brainlab AG", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243633", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-06-12", "submission_number": "K251153", "pathway": "510(k)", "device": "Aurora", "company": "GE Medical Systems Israel", "panel_lead": "Radiology", "primary_product_code": "KPS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251153", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-06-12", "submission_number": "K243234", "pathway": "510(k)", "device": "Second Opinion® CS", "company": "Pearl Inc.", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243234", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-06-10", "submission_number": "K250354", "pathway": "510(k)", "device": "Viz Subdural+, Viz SUBDURAL PLUS", "company": "Viz.ai, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250354", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-06-06", "submission_number": "K251009", "pathway": "510(k)", "device": "Cirrus Resting State fMRI Software", "company": "Sora Neuroscience, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251009", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-06-06", "submission_number": "K242737", "pathway": "510(k)", "device": "Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal", "company": "Empatica S.R.L.", "panel_lead": "Cardiovascular", "primary_product_code": "MWI", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242737", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-06-05", "submission_number": "K251456", "pathway": "510(k)", "device": "BrightHeart View Classifier", "company": "BrightHeart", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251456", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-06-05", "submission_number": "K243667", "pathway": "510(k)", "device": "Sonic DL", "company": "GE Medical Systems, LLC", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243667", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-06-04", "submission_number": "K251397", "pathway": "510(k)", "device": "Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System", "company": "Philips Medical Systems Nederland B.V.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251397", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-06-04", "submission_number": "K250749", "pathway": "510(k)", "device": "PhysCade System", "company": "PhysCade, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "DQK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250749", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-06-04", "submission_number": "K243810", "pathway": "510(k)", "device": "TraumaCad Neo (1.1)", "company": "Brainlab Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243810", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-30", "submission_number": "K251406", "pathway": "510(k)", "device": "BriefCase-Triage", "company": "Aidoc Medical, Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251406", "tracker_id": "aidoc-briefcase-ich", "family_evidence_grade": "C" }, { "decision_date": "2025-05-30", "submission_number": "K250236", "pathway": "510(k)", "device": "Swoop® Portable MR Imaging® System (V2)", "company": "Hyperfine, Inc.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250236", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-30", "submission_number": "K243863", "pathway": "510(k)", "device": "Opulus™ Lymphoma Precision", "company": "Roche Molecular Systems, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243863", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-30", "submission_number": "K243005", "pathway": "510(k)", "device": "AudaxCeph Cephalogram Analysis Software", "company": "Audax d.o.o.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243005", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-30", "submission_number": "K242830", "pathway": "510(k)", "device": "LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer", "company": "Bonraybio Co., LTD.", "panel_lead": "Hematology", "primary_product_code": "POV", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242830", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-30", "submission_number": "DEN240047", "pathway": "De Novo", "device": "Allix5", "company": "Clairity, Inc.", "panel_lead": "Radiology", "primary_product_code": "SEZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240047", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-29", "submission_number": "K250543", "pathway": "510(k)", "device": "Voluson™ Performance 16; Voluson™ Performance 18", "company": "GE Medical Systems Ultrasound and Primary care Diagnostics", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250543", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-28", "submission_number": "K250427", "pathway": "510(k)", "device": "TAIMedImg DeepMets", "company": "Taiwan Medical Imaging Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250427", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-28", "submission_number": "K250367", "pathway": "510(k)", "device": "CoLumboX", "company": "Smart Soft Healthcare AD", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250367", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-28", "submission_number": "K243378", "pathway": "510(k)", "device": "Rapid MLS", "company": "iSchemaview Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243378", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-27", "submission_number": "K250932", "pathway": "510(k)", "device": "DeepRhythmAI", "company": "Medicalgorithmics S.A.", "panel_lead": "Cardiovascular", "primary_product_code": "DQK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250932", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-23", "submission_number": "K250005", "pathway": "510(k)", "device": "Clever One", "company": "Ewoosoft Co., Ltd", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250005", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-23", "submission_number": "K243989", "pathway": "510(k)", "device": "Second Opinion® 3D", "company": "Pearl, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243989", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-23", "submission_number": "K243937", "pathway": "510(k)", "device": "Accuro 3S", "company": "Rivanna Medical, Inc.", "panel_lead": "Radiology", "primary_product_code": "IYO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243937", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-23", "submission_number": "K242594", "pathway": "510(k)", "device": "DEEPECHO", "company": "DeepEcho", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242594", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-21", "submission_number": "K251276", "pathway": "510(k)", "device": "Swoop® Portable MR Imaging® System", "company": "Hyperfine, Inc.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251276", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-21", "submission_number": "K243866", "pathway": "510(k)", "device": "InVision Precision Cardiac Amyloid", "company": "InVision Medical Technology Corporation", "panel_lead": "Cardiovascular", "primary_product_code": "SDJ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243866", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-21", "submission_number": "K243793", "pathway": "510(k)", "device": "EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System", "company": "Philips Ultrasound LLC", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243793", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-21", "submission_number": "K243762", "pathway": "510(k)", "device": "Synapse 3D Base Tools (V7.0)", "company": "FUJIFILM Corporation", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243762", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-21", "submission_number": "K243122", "pathway": "510(k)", "device": "uMR Omega", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243122", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-20", "submission_number": "K250370", "pathway": "510(k)", "device": "SCENARIA View Phase 5.0", "company": "FUJIFILM Corporation", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250370", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-16", "submission_number": "K250086", "pathway": "510(k)", "device": "OTS Hip", "company": "Ortoma AB", "panel_lead": "Neurology", "primary_product_code": "OLO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250086", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-16", "submission_number": "K243617", "pathway": "510(k)", "device": "uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis", "company": "Shanghai United Imaging Healthcare Co.,Ltd.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243617", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-16", "submission_number": "K241671", "pathway": "510(k)", "device": "6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)", "company": "Esaote S.p.A.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241671", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-16", "submission_number": "K240554", "pathway": "510(k)", "device": "InferRead Lung CT.AI", "company": "Infervision Medical Technology Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "OEB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240554", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-14", "submission_number": "K242624", "pathway": "510(k)", "device": "Medical Image Post-processing Software (uOmnispace.CT)", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242624", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-14", "submission_number": "K242437", "pathway": "510(k)", "device": "Smile Dx®", "company": "Cube Click, Inc.", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242437", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-09", "submission_number": "K251126", "pathway": "510(k)", "device": "SKOUT system", "company": "Iterative Health", "panel_lead": "Gastroenterology-Urology", "primary_product_code": "QNP", "fda_url": 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"pathway": "510(k)", "device": "Second Opinion® BLE", "company": "Pearl Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243230", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-09", "submission_number": "K242388", "pathway": "510(k)", "device": "LensHooke X12 PRO Semen Analysis System", "company": "Bonraybio Co., LTD.", "panel_lead": "Hematology", "primary_product_code": "POV", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242388", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-08", "submission_number": "K250226", "pathway": "510(k)", "device": "Clarius Median Nerve AI", "company": "Clarius Mobile Health Corp.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250226", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-07", "submission_number": "K243684", "pathway": "510(k)", "device": "BrightHeart View Classifier", "company": "BrightHeart", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243684", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-05", "submission_number": "K243893", "pathway": "510(k)", "device": "Second Opinion® Pediatric", "company": "Pearl, Inc.", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243893", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-05-02", "submission_number": "K251071", "pathway": "510(k)", "device": "Fetal EchoScan (v1.1)", "company": "BrightHeart", "panel_lead": "Radiology", "primary_product_code": "POK", "fda_url": 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Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati", "company": "Element Science, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "MVK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230022", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-04-30", "submission_number": "K250328", "pathway": "510(k)", "device": "UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250328", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-04-28", "submission_number": "K243376", "pathway": "510(k)", "device": "uAngio AVIVA CX", "company": "Shanghai United Imaging Healthcare Co.,Ltd.", "panel_lead": "Radiology", "primary_product_code": "OWB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243376", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-04-24", "submission_number": "K243239", "pathway": "510(k)", "device": "Lung AI (LAI001)", "company": "Exo Inc", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243239", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-04-23", "submission_number": "K250831", "pathway": "510(k)", "device": "Annalise Enterprise", "company": "Annalise-AI", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250831", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-04-21", "submission_number": "K243651", "pathway": "510(k)", "device": "VersaViewer", "company": "GE Medical Systems SCS", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243651", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-04-17", "submission_number": "K243878", "pathway": "510(k)", "device": "CLARUS (700)", "company": "Carl Zeiss Meditec, Inc.", "panel_lead": "Ophthalmic", "primary_product_code": "QER", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243878", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-04-17", "submission_number": "K242129", "pathway": "510(k)", "device": "VitalRhythm", "company": "VitalConnect, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "DQK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242129", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-04-16", "submission_number": "K243853", "pathway": "510(k)", "device": "Clarius Prostate AI", "company": "Clarius Mobile Health Corp.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243853", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-04-16", "submission_number": "K242500", "pathway": "510(k)", "device": "LARALAB", "company": "LARALAB GmbH", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242500", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-04-15", "submission_number": "K250650", "pathway": "510(k)", "device": "SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option", "company": "Arineta Ltd.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250650", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-04-11", "submission_number": "K250416", "pathway": "510(k)", "device": "GBrain MRI", "company": "Galileo CDS, Inc", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250416", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-04-11", "submission_number": "K243558", "pathway": "510(k)", "device": "Canvas Dx", "company": "Cognoa, Inc.", "panel_lead": "Neurology", "primary_product_code": "QPF", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243558", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-04-11", "submission_number": "K242748", "pathway": "510(k)", "device": "Oncospace", "company": "Oncospace, Inc.", "panel_lead": "Radiology", "primary_product_code": "MUJ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242748", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-04-11", "submission_number": "K242600", "pathway": "510(k)", "device": "Second Opinion Periapical Radiolucency Contours", "company": "Pearl Inc.", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242600", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-04-10", "submission_number": "K250754", "pathway": "510(k)", "device": "cmAngio® (V1.6)", "company": "CureMetrix, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250754", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-04-10", "submission_number": "K250177", "pathway": "510(k)", 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"Augmedics Ltd.", "panel_lead": "Neurology", "primary_product_code": "SBF", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250255", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-03-11", "submission_number": "K241725", "pathway": "510(k)", "device": "Better Diagnostics Caries Assist (BDCA) Version 1.0", "company": "Better Diagnostics AI Corp", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241725", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-03-07", "submission_number": "K242338", "pathway": "510(k)", "device": "Cleerly LABS (v2.0)", "company": "Cleerly, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242338", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-03-06", "submission_number": "K243331", "pathway": "510(k)", "device": "LVivo Seamless", "company": "DiA Imaging Analysis Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243331", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-03-05", "submission_number": "K241770", "pathway": "510(k)", "device": "Prostate MR AI (VA10A)", "company": "Siemens Healthcare GmbH", "panel_lead": "Radiology", "primary_product_code": "QDQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241770", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-03-04", "submission_number": "K243933", "pathway": "510(k)", "device": "Ceevra Reveal 3+", "company": "Ceevra, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243933", 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"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242798", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-02-28", "submission_number": "K241922", "pathway": "510(k)", "device": "Myomics", "company": "Phantomics Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241922", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-02-27", "submission_number": "K241620", "pathway": "510(k)", "device": "ChestView US", "company": "Gleamer SAS", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241620", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-02-26", "submission_number": "K241546", "pathway": "510(k)", "device": "aiCockpit AI Viewer", "company": "Fovia, Inc.", "panel_lead": "Radiology", 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{ "decision_date": "2025-01-10", "submission_number": "K241676", "pathway": "510(k)", "device": "TriVerity", "company": "Inflammatix, Inc.", "panel_lead": "Microbiology", "primary_product_code": "PRE", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241676", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-01-10", "submission_number": "K241009", "pathway": "510(k)", "device": "PeriCALM Patterns 3.0", "company": "PeriGen, Inc.", "panel_lead": "Obstetrics and Gynecology", "primary_product_code": "HGM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241009", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2025-01-07", "submission_number": "K243335", "pathway": "510(k)", "device": "Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", 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"pathway": "510(k)", "device": "EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)", "company": "Ever Fortune.AI, Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241923", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-12-06", "submission_number": "K241543", "pathway": "510(k)", "device": "DrAid™ for Liver Segmentation", "company": "VinBrain Joint Stock Company", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241543", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-12-06", "submission_number": "K240926", "pathway": "510(k)", "device": "PeekMed web", "company": "Peek Health, S.A.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240926", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-12-06", "submission_number": "K240680", "pathway": "510(k)", "device": "CDM Insights", "company": "Oxford Brain Diagnostics Ltd", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240680", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-12-04", "submission_number": "K241197", "pathway": "510(k)", "device": "DeepRhythmAI", "company": "Medicalgorithmics S.A.", "panel_lead": "Cardiovascular", "primary_product_code": "DQK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241197", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-12-03", "submission_number": "K242188", "pathway": "510(k)", "device": "ClearRead CT CAC", "company": "Riverain 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"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242203", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-11-22", "submission_number": "K242094", "pathway": "510(k)", "device": "Dreem 3S", "company": "Beacon Biosignals, Inc.", "panel_lead": "Neurology", "primary_product_code": "OLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242094", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-11-20", "submission_number": "K242359", "pathway": "510(k)", "device": "Strain AI (SAI001)", "company": "Exo Inc", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242359", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-11-19", "submission_number": "K242523", "pathway": "510(k)", "device": "ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia 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"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241633", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-11-15", "submission_number": "K242800", "pathway": "510(k)", "device": "The 5000 Compact Series Ultrasound Systems", "company": "Philips Ultrasound LLC", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242800", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-11-15", "submission_number": "K242130", "pathway": "510(k)", "device": "Koios DS", "company": "Koios Medical, Inc.", "panel_lead": "Radiology", "primary_product_code": "POK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242130", "tracker_id": "koios-ds", "family_evidence_grade": "C" }, { "decision_date": "2024-11-15", "submission_number": "K242062", "pathway": "510(k)", "device": "1CMR Pro", "company": "Mycardium AI Limited", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242062", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-11-15", "submission_number": "K241439", "pathway": "510(k)", "device": "VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage", "company": "Vuno Inc.", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241439", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-11-15", "submission_number": "K240860", "pathway": "510(k)", "device": "EchoGo Amyloidosis (1.0)", "company": "Ultromics Limited", "panel_lead": "Cardiovascular", "primary_product_code": "SDJ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240860", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-11-14", "submission_number": "K242342", "pathway": "510(k)", "device": "Fetal EchoScan", "company": "BrightHeart", "panel_lead": "Radiology", "primary_product_code": "POK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242342", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-11-08", "submission_number": "K240417", "pathway": "510(k)", "device": "ProFound Detection (V4.0)", "company": "iCAD, Inc.", "panel_lead": "Radiology", "primary_product_code": "QDQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240417", "tracker_id": "icad-dbt", "family_evidence_grade": "C" }, { "decision_date": "2024-11-07", "submission_number": "K241719", "pathway": "510(k)", "device": "NeuroICH", "company": "Neurocareai Inc.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241719", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-11-07", "submission_number": "K240712", "pathway": "510(k)", "device": "icobrain aria", "company": "icometrix NV", "panel_lead": "Radiology", "primary_product_code": "QBS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240712", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-11-05", "submission_number": "K241312", "pathway": "510(k)", "device": "TeraRecon Cardiac.Chambers.MR (1.0.0)", "company": "TeraRecon,Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241312", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-10-30", "submission_number": "K241108", "pathway": "510(k)", "device": "RemedyLogic AI MRI Lumbar Spine Reader", "company": "Remedy Logic Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241108", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-10-25", "submission_number": "K243189", "pathway": "510(k)", "device": "TumorSight Viz", "company": "SimBioSys, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243189", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-10-25", "submission_number": "K242215", "pathway": "510(k)", "device": "Neurophet AQUA (V3.1)", "company": "Neurophet, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242215", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-10-22", "submission_number": "K243209", "pathway": "510(k)", "device": "nordicMEDiVA", "company": "NordicNeurolab AS", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243209", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-10-18", "submission_number": "K242837", "pathway": "510(k)", "device": "BriefCase-Triage", "company": "Aidoc Medical, Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242837", "tracker_id": "aidoc-briefcase-ich", "family_evidence_grade": "C" }, { "decision_date": "2024-10-18", "submission_number": "K241490", "pathway": "510(k)", "device": "Contour+ (MVision AI Segmentation)", "company": "MVision AI Oy", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241490", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-10-17", "submission_number": "K241242", "pathway": "510(k)", "device": "SIGNA MAGNUS", "company": "GE Medical Systems, LLC", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241242", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-10-17", "submission_number": "K240408", "pathway": "510(k)", "device": "REMI-AI Rapid Detection Module (REMI-AI RDM)", "company": "Epitel, Inc", "panel_lead": "Neurology", "primary_product_code": "OMB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240408", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-10-16", "submission_number": "K241481", "pathway": "510(k)", "device": "xvision Spine System", "company": "Augmedics Ltd.", "panel_lead": "Neurology", "primary_product_code": "SBF", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241481", "tracker_id": "", 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"2024-10-04", "submission_number": "K240553", "pathway": "510(k)", "device": "LVivo Software Application", "company": "DiA Imaging Analysis Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240553", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-10-02", "submission_number": "K242005", "pathway": "510(k)", "device": "Versana Premier; Versana Premier Lotus; LOGIQ F", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242005", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-10-02", "submission_number": "K241561", "pathway": "510(k)", "device": "MammoScreen BD", "company": "Therapixel", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241561", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-10-01", "submission_number": "K241331", "pathway": "510(k)", "device": "MuscleView", "company": "Springbok, Inc.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241331", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-10-01", "submission_number": "K240943", "pathway": "510(k)", "device": "LungVision", "company": "BodyVision Medical Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240943", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-09-27", "submission_number": "K241480", "pathway": "510(k)", "device": "JBS-LVO", "company": "JLK, Inc.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241480", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-09-27", "submission_number": "K240993", "pathway": "510(k)", "device": "encevis (2.1)", "company": "AIT Austrian Institute of Technology GmbH", "panel_lead": "Neurology", "primary_product_code": "OMB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240993", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-09-27", "submission_number": "K240369", "pathway": "510(k)", "device": "CAC (gated) Algorithm", "company": "BunkerHill Health", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240369", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-09-24", "submission_number": "K242292", "pathway": "510(k)", "device": "uAI Easy Triage ICH", "company": "Shanghai United Imaging Intelligence Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242292", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-09-23", "submission_number": "P140011/S008", "pathway": "PMA", "device": "MAMMOMAT B.brilliant with Tomosynthesis Option", "company": "SIEMENS MEDICAL SOLUTIONS USA, INC.", "panel_lead": "Radiology", "primary_product_code": "OTE", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140011/S008", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-09-23", "submission_number": "K240013", "pathway": "510(k)", "device": "EchoGo Heart Failure (2.0)", "company": "Ultromics Limited", "panel_lead": "Cardiovascular", "primary_product_code": "QUO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240013", "tracker_id": "echogo-hf", "family_evidence_grade": "C" }, { "decision_date": "2024-09-20", "submission_number": "K240036", "pathway": "510(k)", "device": "PIUR tUS Infinity", "company": "PIUR Imaging GmbH", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240036", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-09-13", "submission_number": "K240929", "pathway": "510(k)", "device": "Sleep Apnea Notification Feature (SANF)", "company": "Apple Inc.", "panel_lead": "Anesthesiology", "primary_product_code": "QZW", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240929", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-09-12", "submission_number": "K241582", "pathway": "510(k)", "device": "Aplio i900/i800/i700 Diagnostic 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"family_evidence_grade": "not graded" }, { "decision_date": "2024-09-11", "submission_number": "K241380", "pathway": "510(k)", "device": "FETOLY-HEART", "company": "Diagnoly", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241380", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-09-10", "submission_number": "K240094", "pathway": "510(k)", "device": "LumiNE US; Lumi", "company": "Augmedit B.V.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240094", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-09-09", "submission_number": "K241681", "pathway": "510(k)", "device": "Overjet Image Enhancement Assist", "company": "Overjet Inc", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241681", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-09-09", "submission_number": "K240791", "pathway": "510(k)", "device": "ADAS 3D", "company": "Adas3D Medical S.L", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240791", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-09-09", "submission_number": "K240697", "pathway": "510(k)", "device": "See-Mode Augmented Reporting Tool, Thyroid (SMART-T)", "company": "See-Mode Technologies Pte. Ltd.", "panel_lead": "Radiology", "primary_product_code": "QDQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240697", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-09-06", "submission_number": "K240411", "pathway": "510(k)", "device": "uAI Portal", "company": "Shanghai United Imaging Intelligence Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240411", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-09-05", "submission_number": "K233998", "pathway": "510(k)", "device": "TRAQinform IQ", "company": "AIQ Global, Inc.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233998", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-09-04", "submission_number": "K233977", "pathway": "510(k)", "device": "Velacur", "company": "Sonic Incytes", "panel_lead": "Radiology", "primary_product_code": "IYO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233977", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-08-30", "submission_number": "K242300", "pathway": "510(k)", "device": "MI View&GO", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242300", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-08-30", "submission_number": "K242275", "pathway": "510(k)", "device": "syngo.via MI Workflows; Scenium; syngo MBF", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242275", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-08-30", "submission_number": "K241847", "pathway": "510(k)", "device": "Imbio PHA (4.0.0)", "company": "Imbio, Inc", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241847", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-08-30", "submission_number": "K241585", "pathway": "510(k)", "device": "uMI Panorama", "company": "Shanghai United Imaging Healthcare Co.,Ltd.", "panel_lead": "Radiology", "primary_product_code": "KPS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241585", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-08-30", "submission_number": "K240003", "pathway": "510(k)", "device": "Velmeni for Dentists (V4D)", "company": "Velmeni Inc.", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240003", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-08-29", "submission_number": "K233826", "pathway": "510(k)", "device": "Kosmos", "company": "EchoNous, Inc.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233826", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-08-27", "submission_number": "K241684", "pathway": "510(k)", "device": "Overjet Charting Assist", "company": "Overjet, Inc", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241684", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-08-22", "submission_number": "K241098", "pathway": "510(k)", "device": "NeuroQuant", "company": "CorTechs Labs, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241098", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-08-21", "submission_number": "K240290", "pathway": "510(k)", "device": "AiMIFY (1.x)", "company": "Subtle Medical, Inc.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240290", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-08-20", "submission_number": "K241496", "pathway": "510(k)", "device": "Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241496", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-08-20", "submission_number": "K240200", "pathway": "510(k)", "device": "HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece", "company": "Procept BioRobotics", "panel_lead": "General and Plastic Surgery", "primary_product_code": "PZP", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240200", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-08-19", "submission_number": "K241440", "pathway": "510(k)", "device": "HealthCCSng", "company": "Nano-X AI Ltd.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241440", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-08-16", "submission_number": "K240740", "pathway": "510(k)", "device": "qCT LN Quant", "company": "Qure.ai Technologies", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240740", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-08-16", "submission_number": "K233755", "pathway": "510(k)", "device": "HeartKey® Rhythm", "company": "B-Secur Limited", "panel_lead": "Cardiovascular", "primary_product_code": "DQK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233755", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-08-15", "submission_number": "K241596", "pathway": "510(k)", "device": "uMI Panvivo", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "KPS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241596", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-08-15", "submission_number": "K241211", "pathway": "510(k)", "device": "CoLumbo", "company": "Smart Soft Healthcare", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241211", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-08-13", "submission_number": "K241429", "pathway": "510(k)", "device": "ECHELON Synergy MRI System", "company": "FUJIFILM Healthcare Corporation", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241429", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-08-12", "submission_number": "K242054", "pathway": "510(k)", "device": "OptimMRI (v2)", "company": "Rebrain, SAS", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242054", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-08-08", 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"family_evidence_grade": "not graded" }, { "decision_date": "2024-07-16", "submission_number": "K240944", "pathway": "510(k)", "device": "Swoop® Portable MR Imaging® System", "company": "Hyperfine, Inc.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240944", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-07-15", "submission_number": "K240285", "pathway": "510(k)", "device": "Huxley SANSA Home Sleep Apnea Test (1000-00)", "company": "Huxley Medical", "panel_lead": "Anesthesiology", "primary_product_code": "MNR", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240285", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-07-12", "submission_number": "K241727", "pathway": "510(k)", "device": "BriefCase-Triage", "company": "Aidoc Medical, Ltd.", "panel_lead": "Radiology", "primary_product_code": 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"SubtleSYNTH (1.x)", "company": "Subtle Medical, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241329", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-07-03", "submission_number": "K241508", "pathway": "510(k)", "device": "SKOUT® system", "company": "Iterative Scopes, Inc.", "panel_lead": "Gastroenterology-Urology", "primary_product_code": "QNP", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241508", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-07-02", "submission_number": "K240736", "pathway": "510(k)", "device": "SMART Bun-Yo-Matic X-Ray", "company": "Disior Ltd", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240736", "tracker_id": "", "family_evidence_grade": "not graded" }, { 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"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240582", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-06-21", "submission_number": "K240631", "pathway": "510(k)", "device": "V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System", "company": "Samsung Medison Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240631", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-06-21", "submission_number": "K240465", "pathway": "510(k)", "device": "O-arm O2 Imaging System", "company": "Medtronic Navigation, Inc", "panel_lead": "Radiology", "primary_product_code": "OWB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240465", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-06-21", "submission_number": "K233549", "pathway": "510(k)", "device": "Tempus ECG-AF", "company": "Tempus AI, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "SBQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233549", "tracker_id": "tempus-ecg-af", "family_evidence_grade": "C" }, { "decision_date": "2024-06-21", "submission_number": "K233253", "pathway": "510(k)", "device": "eCARTv5 Clinical Deterioration Suite (“eCART”)", "company": "AgileMD, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "QNL", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233253", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-06-21", "submission_number": "K233196", "pathway": "510(k)", "device": "Medihub Prostate", "company": "JLK Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233196", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-06-20", "submission_number": "K240642", "pathway": "510(k)", "device": "SMART Bun-Yo-Matic CT", "company": "Disior Ltd", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240642", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-06-14", "submission_number": "K241083", "pathway": "510(k)", "device": "SIS System", "company": "Surgical Information Sciences, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241083", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-06-14", "submission_number": "K233955", "pathway": "510(k)", "device": "Clarius OB AI", "company": "Clarius Mobile Health Corp.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233955", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-06-13", "submission_number": "K233925", "pathway": "510(k)", "device": "Relu Creator", "company": "Relu BV", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233925", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-06-13", "submission_number": "K233662", "pathway": "510(k)", "device": "Radiography 7300 C", "company": "Philips Medical Systems DMC GmbH", "panel_lead": "Radiology", "primary_product_code": "KPR", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233662", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-06-12", "submission_number": "K240516", "pathway": "510(k)", "device": "RS85 Diagnostic Ultrasound System", "company": "Samsung Medison Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240516", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-06-07", "submission_number": "K241038", "pathway": "510(k)", "device": "Cardiac CT Function Software Application", "company": "Circle Cardiovascular Imaging", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241038", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-06-07", "submission_number": "K234042", "pathway": "510(k)", "device": "EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)", "company": "Ever Fortune.AI Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K234042", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-06-07", "submission_number": "K232035", "pathway": "510(k)", "device": "Impala", "company": "AliveCor, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "DPS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232035", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-06-07", "submission_number": "K231010", "pathway": "510(k)", "device": "Corvair", "company": "AliveCor, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "MHX", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231010", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-05-31", "submission_number": "K240612", "pathway": "510(k)", "device": "CINA-VCF", "company": "Avicenna.AI", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240612", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-05-24", "submission_number": "K240769", "pathway": "510(k)", "device": "LVivo IQS", "company": "DiA Imaging Analysis Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240769", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-05-24", "submission_number": "K234154", "pathway": "510(k)", "device": "uPMR 790", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "OUO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K234154", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-05-23", "submission_number": "K240294", "pathway": "510(k)", "device": "Syngo Carbon Enterprise Access (VA40A)", "company": "Siemens Healthcare GmbH", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240294", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-05-23", "submission_number": "K233108", "pathway": "510(k)", "device": "VinDr-Mammo", "company": "VinBigData Joint Stock Company", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233108", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-05-21", "submission_number": "K233543", "pathway": "510(k)", "device": "YSIO X.pree", "company": "Siemens Medical Solutions", "panel_lead": "Radiology", "primary_product_code": "KPR", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233543", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-05-17", "submission_number": "K233209", "pathway": "510(k)", "device": "uOmnispace.CT", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233209", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-05-17", "submission_number": "DEN230035", "pathway": "De Novo", "device": "DentalMonitoring", "company": "Dental Monitoring SAS", "panel_lead": "Dental", "primary_product_code": "SBC", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230035", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-05-16", "submission_number": "K233625", "pathway": "510(k)", "device": "RAYDENT SW", "company": "RAY Co., Ltd.", "panel_lead": "Dental", "primary_product_code": "PNN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233625", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-05-15", "submission_number": "K241112", "pathway": "510(k)", "device": "BriefCase-Quantification", "company": "Aidoc Medical, Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241112", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-05-15", "submission_number": "K233247", "pathway": "510(k)", "device": "Heuron ICH", "company": "Heuron Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233247", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-05-15", "submission_number": "DEN230043", "pathway": "De Novo", "device": "Notal Vision Home Optical Coherence Tomography 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"2024-05-07", "submission_number": "K232928", "pathway": "510(k)", "device": "DeepContour (V1.0)", "company": "Wisdom Technologies., Inc.", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232928", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-05-03", "submission_number": "K233687", "pathway": "510(k)", "device": "ECHELON Synergy V10.0", "company": "Fujifilm Healthcare Americas Corporation", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233687", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-05-03", "submission_number": "K232491", "pathway": "510(k)", "device": "CT 5300", "company": "Philips Healthcare (Suzhou) Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": 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"510(k)", "device": "Rapid", "company": "iSchema View Inc.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233582", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-04-19", "submission_number": "K240781", "pathway": "510(k)", "device": "SKOUT® system", "company": "Iterative Scopes, Inc.", "panel_lead": "Gastroenterology-Urology", "primary_product_code": "QNP", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240781", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-04-17", "submission_number": "K233186", "pathway": "510(k)", "device": "uOmnispace.MR", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233186", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-04-15", "submission_number": "K240773", "pathway": "510(k)", "device": "VisAble.IO", "company": "Techsomed", "panel_lead": "Radiology", "primary_product_code": "QTZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240773", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-04-12", "submission_number": "K240238", "pathway": "510(k)", "device": "Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240238", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-04-11", "submission_number": "K233698", "pathway": "510(k)", "device": "True Enhance DL", "company": "GE Healthcare Japan Corporation", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233698", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-04-10", "submission_number": "K240744", "pathway": "510(k)", "device": "uMR 680", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240744", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-04-09", "submission_number": "DEN230023", "pathway": "De Novo", "device": "Rho", "company": "16 Bit Inc", "panel_lead": "Radiology", "primary_product_code": "SAO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230023", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-04-08", "submission_number": "K240291", "pathway": "510(k)", "device": "EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM", "company": "Ever Fortune.AI, Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240291", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-04-05", "submission_number": "K233666", "pathway": "510(k)", "device": "CorVista System with PH Add-On", "company": "Analytics for Life, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "SAT", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233666", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-04-05", "submission_number": "K233249", "pathway": "510(k)", "device": "APPRAISE-HRI", "company": "The Surgeon General, Department of the Army (TSG-DA)", "panel_lead": "Cardiovascular", "primary_product_code": "SAR", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233249", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-04-04", "submission_number": "K240172", "pathway": "510(k)", "device": "Preview Shoulder", "company": "Genesis Software Innovations", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240172", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-04-03", "submission_number": "K233618", "pathway": "510(k)", "device": "Oxevision Sleep Device", "company": "Oxehealth Limited", "panel_lead": "Neurology", "primary_product_code": "LEL", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233618", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-04-03", "submission_number": "K232899", "pathway": "510(k)", "device": "AI-Rad Companion Organs RT", "company": "Siemens Medical Solutions U.S.A.", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232899", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-04-02", "submission_number": "K232835", "pathway": "510(k)", "device": "Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232835", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-04-02", "submission_number": "DEN230036", "pathway": "De Novo", "device": "Sepsis ImmunoScore", "company": "Prenosis, Inc.", "panel_lead": "General Hospital", "primary_product_code": "SAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230036", "tracker_id": "sepsis-immunoscore", "family_evidence_grade": "B" }, { "decision_date": "2024-04-01", "submission_number": "K233676", "pathway": "510(k)", "device": "Us2.v2", "company": "Eko.ai Pte. 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"K233409", "pathway": "510(k)", "device": "Eko Low Ejection Fraction Tool (ELEFT)", "company": "Eko Health, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "QYE", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233409", "tracker_id": "eko-low-ef", "family_evidence_grade": "B" }, { "decision_date": "2024-03-26", "submission_number": "K233650", "pathway": "510(k)", "device": "SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233650", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-03-22", "submission_number": "K240540", "pathway": "510(k)", "device": "uMR Omega", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": 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"submission_number": "K233753", "pathway": "510(k)", "device": "AI-Rad Companion (Pulmonary)", "company": "Siemens Healthcare GmbH", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233753", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-03-20", "submission_number": "K234047", "pathway": "510(k)", "device": "Automatic Registration", "company": "Brainlab AG", "panel_lead": "Neurology", "primary_product_code": "OLO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K234047", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-03-15", "submission_number": "K233342", "pathway": "510(k)", "device": "CINA-ASPECTS", "company": "Avicenna.AI", "panel_lead": "Radiology", "primary_product_code": "POK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233342", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-03-13", "submission_number": "K233968", "pathway": "510(k)", "device": "CINA-iPE", "company": "Avicenna.AI", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233968", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-03-11", "submission_number": "K232140", "pathway": "510(k)", "device": "OTS Hip", "company": "Ortoma AB", "panel_lead": "Neurology", "primary_product_code": "OLO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232140", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-03-08", "submission_number": "K233438", "pathway": "510(k)", "device": "SleepStageML", "company": "Beacon Biosignals, Inc.", "panel_lead": "Neurology", "primary_product_code": "OLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233438", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-03-07", "submission_number": "K233692", "pathway": "510(k)", "device": "Voluson Signature 20, Voluson Signature 18", "company": "GE Medical Systems Ultrasound and Primary care Diagnostics,", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233692", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-03-06", "submission_number": "K231677", "pathway": "510(k)", "device": "EdgeFlow UH10", "company": "Edgecare Inc.", "panel_lead": "Radiology", "primary_product_code": "IYO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231677", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-03-04", "submission_number": "K233738", "pathway": "510(k)", "device": "Overjet Caries Assist-Pediatric", "company": "Overjet, Inc", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233738", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-03-01", "submission_number": "K233030", "pathway": "510(k)", "device": "BoneMRI", "company": "MRIguidance B.V", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233030", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-03-01", "submission_number": "K231690", "pathway": "510(k)", "device": "iCAS-LV", "company": "HighRAD Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231690", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-02-29", 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"primary_product_code": "QRY", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232148", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-02-15", "submission_number": "K232915", "pathway": "510(k)", "device": "EpiMonitor", "company": "Empatica Srl", "panel_lead": "Neurology", "primary_product_code": "POS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232915", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-02-13", "submission_number": "K233788", "pathway": "510(k)", "device": "EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System", "company": "Philips Ultrasound LLC", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233788", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-02-13", "submission_number": "K231855", "pathway": "510(k)", "device": "QOCA® image Smart RT Contouring System", "company": "Quanta Computer Inc.", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231855", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-02-09", "submission_number": "K231355", "pathway": "510(k)", "device": "Aurora", "company": "EnsoData", "panel_lead": "Anesthesiology", "primary_product_code": "MNR", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231355", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-02-08", "submission_number": "K233080", "pathway": "510(k)", "device": "HealthFLD", "company": "Nano-X AI Ltd.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233080", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-02-06", "submission_number": "DEN230041", "pathway": "De Novo", "device": "Sleep Apnea Feature", "company": "Samsung Electronics Co., Ltd", "panel_lead": "Anesthesiology", "primary_product_code": "QZW", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230041", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-02-05", "submission_number": "K232363", "pathway": "510(k)", "device": "Viz HDS, Viz Volume Plus, Viz ICH+", "company": "Viz.ai, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232363", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-01-31", "submission_number": "K231396", "pathway": "510(k)", "device": "CEPHX- Cephalometric Analysis Software", "company": "Orca Dental AI LTD", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231396", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-01-31", "submission_number": "DEN210035", "pathway": "De Novo", "device": "“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”", "company": "Hologic Inc.", "panel_lead": "Pathology", "primary_product_code": "QYV", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210035", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-01-24", "submission_number": "K233195", "pathway": "510(k)", "device": "Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233195", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-01-19", "submission_number": "K233728", "pathway": "510(k)", "device": "SIGNA Champion", "company": "GE Healthcare (Tianjin) Company Limited", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233728", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-01-19", "submission_number": "K232156", "pathway": "510(k)", "device": "Rapid ASPECTS (v3)", "company": "iSchemaView, Inc.", "panel_lead": "Radiology", "primary_product_code": "POK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232156", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-01-18", "submission_number": "K232698", "pathway": "510(k)", "device": "NemoScan", "company": "Software Nemotec S.L.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232698", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-01-17", "submission_number": "K231871", "pathway": "510(k)", "device": "Radify Triage", "company": "Envisionit DeepAI Ltd", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231871", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-01-16", "submission_number": "K233512", "pathway": "510(k)", "device": "Rapid (6.0)", "company": "iSchemaView, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233512", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-01-13", "submission_number": "K233216", "pathway": "510(k)", "device": "CLEWICU System", "company": "Clew Medical Ltd.", "panel_lead": "Cardiovascular", "primary_product_code": "QNL", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233216", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-01-12", "submission_number": "K233964", "pathway": "510(k)", "device": "GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)", "company": "Cosmo Artificial Intelligence - AI Ltd", "panel_lead": "Gastroenterology-Urology", "primary_product_code": "QNP", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233964", "tracker_id": "gi-genius", "family_evidence_grade": "A" }, { "decision_date": "2024-01-12", "submission_number": "K233677", "pathway": "510(k)", "device": "Biograph VK10", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "KPS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233677", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-01-12", "submission_number": "DEN230008", "pathway": "De Novo", "device": "DermaSensor", "company": "DermaSensor Inc.", "panel_lead": "General and Plastic Surgery", "primary_product_code": "QZS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230008", "tracker_id": "dermasensor", "family_evidence_grade": "B" }, { "decision_date": "2024-01-12", "submission_number": "DEN220040", "pathway": "De Novo", "device": "Fibresolve", "company": "Imvaria, Inc", "panel_lead": "Radiology", "primary_product_code": "QWO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220040", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-01-11", "submission_number": "K232250", "pathway": "510(k)", "device": "SurgiCount+ System", "company": "Stryker Instruments", "panel_lead": "General Hospital", "primary_product_code": "PBZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232250", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-01-11", "submission_number": "DEN220066", "pathway": "De Novo", "device": "BrainSee", "company": "Darmiyan, Inc.", "panel_lead": "Neurology", "primary_product_code": "QWT", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220066", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-01-08", "submission_number": "K232412", "pathway": "510(k)", "device": "LungQ v3.0.0", "company": "Thirona BV", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232412", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-01-08", "submission_number": "K231324", "pathway": "510(k)", "device": "DASI Dimensions (V1.0)", "company": "DASI Simulations", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231324", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-01-07", "submission_number": "K231068", "pathway": "510(k)", "device": "autoSCORE", "company": "Holberg EEG AS", "panel_lead": "Neurology", "primary_product_code": "OMB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231068", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-01-05", "submission_number": "K231917", "pathway": "510(k)", "device": "VEA Align", "company": "EOS imaging", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231917", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-01-04", "submission_number": "K232808", "pathway": "510(k)", "device": "Butterfly iQ3 Ultrasound System", "company": "Butterfly Network, Inc.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232808", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2024-01-03", "submission_number": "K231779", "pathway": "510(k)", "device": "REMI AI Discrete Detection Module", "company": "Epitel, Inc.", "panel_lead": "Neurology", "primary_product_code": "OMB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231779", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-26", "submission_number": "K231130", "pathway": "510(k)", "device": "TumorSight Viz", "company": "SimBioSys, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231130", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-22", "submission_number": "K232535", "pathway": "510(k)", "device": "MAGNETOM Sola; MAGNETOM Altea", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232535", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-22", "submission_number": "K232479", "pathway": "510(k)", "device": "ART-Plan", "company": "TheraPanacea", "panel_lead": "Radiology", "primary_product_code": "MUJ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232479", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-22", "submission_number": "K231805", "pathway": "510(k)", "device": "qXR-LN", "company": "Qure.ai Technologies", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231805", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-21", "submission_number": "K233112", "pathway": "510(k)", "device": "HM70 EVO Diagnostic Ultrasound System", "company": "Samsung Medison CO., LTD.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233112", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-20", "submission_number": "K233176", "pathway": "510(k)", "device": "uOmnispace.MI", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233176", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-20", "submission_number": "K230850", "pathway": "510(k)", "device": "United Orthopedic Knee Patient Specific Instrumentation", "company": "Enhatch, Inc.", "panel_lead": "Orthopedic", "primary_product_code": "OOG", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230850", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-18", "submission_number": "K231929", "pathway": "510(k)", "device": "iQ-solutions", "company": "Sydney Neuroimaging Analysis Centre Pty Ltd", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231929", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-18", "submission_number": "K231587", "pathway": "510(k)", "device": "MAGNETOM Cima.X", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231587", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-15", "submission_number": "K232384", "pathway": "510(k)", "device": "Videa Dental Assist", "company": "VideaHealth, Inc.", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232384", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-15", "submission_number": "K230751", "pathway": "510(k)", "device": "EW10-EC02 Endoscopy Support Program", "company": "FUJIFILM Corporation", "panel_lead": "Gastroenterology-Urology", "primary_product_code": "QNP", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230751", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-14", "submission_number": "K231570", "pathway": "510(k)", "device": "StrokeViewer Perfusion", "company": "NICo-Lab B.V.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231570", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-13", "submission_number": "K232237", "pathway": "510(k)", "device": "Tyto Insights for Wheeze Detection", "company": "Tyto Care Ltd.", "panel_lead": "Anesthesiology", "primary_product_code": "PHZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232237", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-13", "submission_number": "K232231", "pathway": "510(k)", "device": "QP-Brain®", "company": "Quibim S.L.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232231", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-12", "submission_number": "DEN230027", "pathway": "De Novo", "device": "NaviCam ProScan", "company": "Ankon Technologies co., ltd", "panel_lead": "Gastroenterology-Urology", "primary_product_code": "QZF", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230027", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-11", "submission_number": "K232096", "pathway": "510(k)", "device": "Transpara Density 1.0.0", "company": "Screenpoint Medical B.V.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232096", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-08", "submission_number": "K231898", "pathway": "510(k)", "device": "DTX Studio Clinic (4.0)", "company": "Nobel Biocare AB", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231898", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-08", "submission_number": "K223757", "pathway": "510(k)", "device": "Bonelogic", "company": "Disior Ltd", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223757", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-07", "submission_number": "K232661", "pathway": "510(k)", "device": "Myocardial Strain Software Application", "company": "Circle Cardiovascular Imaging", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232661", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-07", "submission_number": "K232381", "pathway": "510(k)", "device": "LOGIQ Totus", "company": "GE Medical Systems Ultrasound and Primary care Diagnostics,", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232381", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-06", "submission_number": "K233562", "pathway": "510(k)", "device": "LINQ II Insertable Cardiac Monitor", "company": "Medtronic, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "MXD", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233562", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-06", "submission_number": "K233334", "pathway": "510(k)", "device": "Aquilion Serve SP (TSX-307B/1) V1.3", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233334", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-05", "submission_number": "K233568", "pathway": "510(k)", "device": "Ceevra Reveal 3+", "company": "Ceevra, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233568", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-05", "submission_number": "K232440", "pathway": "510(k)", "device": "Adravision Perio", "company": "Adra Corporation", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232440", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-12-01", "submission_number": "K232856", "pathway": "510(k)", "device": "Syngo Carbon Clinicals", "company": "Siemens Healthcare GmbH", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232856", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-11-30", "submission_number": "K233545", "pathway": "510(k)", "device": "EPIQ Series Diagnostic Ultrasound System", "company": "Philips Ultrasound LLC", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233545", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-11-29", "submission_number": "K230179", "pathway": "510(k)", "device": "6440 MyLabX90", "company": "Esaote S.p.A.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230179", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-11-28", "submission_number": "K232000", "pathway": "510(k)", "device": "syngo.via MI Workflows; Scenium; syngo MBF", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232000", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-11-28", "submission_number": "K231631", "pathway": "510(k)", "device": "BriefCase-Quantification", "company": "Aidoc Medical, Ltd.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231631", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-11-27", "submission_number": "K233243", "pathway": "510(k)", "device": "ClearPoint System (Software Version 2.2)", "company": "ClearPoint Neuro Inc.", "panel_lead": "Neurology", "primary_product_code": "HAW", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233243", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-11-21", "submission_number": "K232496", "pathway": "510(k)", "device": "Brainomix 360 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"2023-11-14", "submission_number": "K232494", "pathway": "510(k)", "device": "MAGNETOM Avanto fit; MAGNETOM Skyra fit", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232494", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-11-13", "submission_number": "K232257", "pathway": "510(k)", "device": "Clarius Bladder AI", "company": "Clarius Mobile Health Corp.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232257", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-11-13", "submission_number": "K232083", "pathway": "510(k)", "device": "BriefCase-Quantification", "company": "Aidoc Medical, Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232083", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-11-09", "submission_number": "K231617", "pathway": "510(k)", "device": "MAGNETOM Free.Max; MAGNETOM Free.Star", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231617", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-11-09", "submission_number": "K223754", "pathway": "510(k)", "device": "BraveCX", "company": "Bering Ltd", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223754", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-11-08", "submission_number": "K231765", "pathway": "510(k)", "device": "Contour ProtégéAI", "company": "MIM Software Inc.", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231765", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-11-08", "submission_number": "K230534", "pathway": "510(k)", "device": "BriefCase-Quantification", "company": "Aidoc Medical, Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230534", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-11-07", "submission_number": "K231989", "pathway": "510(k)", "device": "LOGIQ E10s, LOGIQ Fortis", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostic,", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231989", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-11-07", "submission_number": "K231966", "pathway": "510(k)", "device": "LOGIQ E10", "company": "GE Medical Systems Ultrasound and Primary care Diagnostics,", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231966", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-11-06", "submission_number": "K231470", "pathway": "510(k)", "device": "Lunit INSIGHT DBT", "company": "Lunit Inc.", "panel_lead": "Radiology", "primary_product_code": "QDQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231470", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-11-03", "submission_number": "K231955", "pathway": "510(k)", "device": "aprevo® Digital Segmentation", "company": "Carlsmed, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231955", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-30", "submission_number": "K232751", "pathway": "510(k)", "device": "BriefCase-Triage", "company": "Aidoc Medical, Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232751", "tracker_id": "aidoc-briefcase-ich", "family_evidence_grade": "C" }, { "decision_date": "2023-10-30", "submission_number": "K232145", "pathway": "510(k)", "device": "ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232145", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-30", "submission_number": "K231965", "pathway": "510(k)", "device": "Voluson Expert 22, Voluson Expert 20, Voluson Expert 18", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics,", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231965", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-27", "submission_number": "K232045", "pathway": "510(k)", "device": "MeVis Liver Suite", "company": "MeVis Medical Solutions AG", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232045", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-27", "submission_number": "K230854", "pathway": "510(k)", "device": "SwiftMR", "company": "AIRS Medical Inc.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230854", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-26", "submission_number": "K232500", "pathway": "510(k)", "device": "Lumify Diagnostic Ultrasound System", "company": "Philips Ultrasound", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232500", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-25", "submission_number": "K232436", "pathway": "510(k)", "device": "Rapid SDH", "company": "iSchemaView, Inc.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232436", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-25", "submission_number": "K230842", "pathway": "510(k)", "device": "SignalHF (IM008)", "company": "Implicity Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "QNL", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230842", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-23", "submission_number": "K232305", "pathway": "510(k)", "device": "AI-Rad Companion Brain MR", "company": "Siemens Medical Solutions U.S.A.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232305", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-23", "submission_number": "K231764", "pathway": "510(k)", "device": "Ultrasound System 1300", "company": "BK Medical Aps", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231764", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-23", "submission_number": "K231560", "pathway": "510(k)", "device": "MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231560", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-20", "submission_number": "K230209", "pathway": "510(k)", "device": "Sonix Health", "company": "Ontact Health Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230209", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-13", "submission_number": "K231642", "pathway": "510(k)", "device": "Veuron-Brain-pAb3", "company": "Heuron Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231642", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-13", "submission_number": "K230370", "pathway": "510(k)", "device": "SpotLight/SpotLight Duo (with DLIR option)", "company": "Arineta Ltd.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230370", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-11", "submission_number": "K230220", "pathway": "510(k)", "device": "NeuViz 128 Multi-Slice CT Scanner System", "company": "Neusoft Medical Systems Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230220", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-06", "submission_number": "K232787", "pathway": "510(k)", "device": "ScanNav Anatomy Peripheral Nerve Block", "company": "Intelligent Ultrasound Limited", "panel_lead": "Anesthesiology", "primary_product_code": "QRG", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232787", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-06", "submission_number": "K232760", "pathway": "510(k)", "device": "Swoop® Portable MR Imaging System®", "company": "Hyperfine, Inc.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232760", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-06", "submission_number": "K230144", "pathway": "510(k)", "device": "Denti.AI Detect", "company": "Denti.AI Technology, Inc.", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230144", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-06", "submission_number": "K223905", "pathway": "510(k)", "device": "Vivio® LVEDP System", "company": "Avicena, LLC", "panel_lead": "Cardiovascular", "primary_product_code": "QUO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223905", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-05", "submission_number": "K232704", "pathway": "510(k)", "device": "Clarius Ultrasound Scanner", "company": "Clarius Mobile Health Corp.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232704", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-05", "submission_number": "K232367", "pathway": "510(k)", "device": "cmAngio® V1.0", "company": "CureMetrix, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232367", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-05", "submission_number": "K231001", "pathway": "510(k)", "device": "DeepTek CXR Analyzer v1.0", "company": "DeepTek Medical Imaging Pvt Ltd", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231001", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-04", "submission_number": "K232023", "pathway": "510(k)", "device": "Momentum Spine", "company": "Momentum Health Inc.", "panel_lead": "Radiology", "primary_product_code": "LDK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232023", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-04", "submission_number": "K231398", "pathway": "510(k)", "device": "VUNO Med-DeepBrain", "company": "VUNO Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231398", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-04", "submission_number": "K231025", "pathway": "510(k)", "device": "EFAI NeuroSuite CT ICH Assessment System", "company": "Ever Fortune.AI Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231025", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-03", "submission_number": "K232712", "pathway": "510(k)", "device": "uMI Panorama", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "KPS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232712", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-03", "submission_number": "K231772", "pathway": "510(k)", "device": "V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System", "company": "Samsung Medison Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231772", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-10-03", "submission_number": "K230085", "pathway": "510(k)", "device": "Lung-CAD", "company": "Imagen Technologies, Inc", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230085", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-29", "submission_number": "K230045", "pathway": "510(k)", "device": "HipCheck", "company": "Stryker Corp.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230045", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-28", "submission_number": "K232699", "pathway": "510(k)", "device": "Low Ejection Fraction AI-ECG Algorithm", "company": "Anumana, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "QYE", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232699", "tracker_id": "anumana-ecg-ai-lef", "family_evidence_grade": "A" }, { "decision_date": "2023-09-28", "submission_number": "K231837", "pathway": "510(k)", "device": "Brainomix 360 Triage LVO", "company": "Brainomix Limited", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231837", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-27", "submission_number": "K232616", "pathway": "510(k)", "device": "Volta AF-Xplorer", "company": "Volta Medical", "panel_lead": "Cardiovascular", "primary_product_code": "DQK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232616", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-26", "submission_number": "K230252", "pathway": "510(k)", "device": "OFIX MIS App", "company": "Orthofix US LLC", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230252", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-25", "submission_number": "K231928", "pathway": "510(k)", "device": "EFAI RTSUITE CT HCAP-Segmentation System", "company": "Ever Fortune.AI Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231928", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-22", "submission_number": "K231767", "pathway": "510(k)", "device": "Annalise Enterprise CTB Triage Trauma", "company": "Annalise-AI Pty Ltd", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231767", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-22", "submission_number": "K231384", "pathway": "510(k)", "device": "Annalise Enterprise CTB Triage Trauma", "company": "Annalise-AI Pty Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231384", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-22", "submission_number": "K231149", "pathway": "510(k)", "device": "qXR-CTR", "company": "Qure.ai Technologies", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231149", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-22", "submission_number": "K223659", "pathway": "510(k)", "device": "Jazz", "company": "AI Medical AG", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223659", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-21", "submission_number": "K231678", "pathway": "510(k)", "device": "Overjet Periapical Radiolucency Assist", "company": "Overjet, Inc", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231678", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-19", "submission_number": "K231281", "pathway": "510(k)", "device": "Aquilion Serve (TSX-307A/1) V1.3", "company": "Canon 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"510(k)", "device": "XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "JAA", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232526", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-12", "submission_number": "K231748", "pathway": "510(k)", "device": "Cartesion Prime (PCD-1000A/3) V10.15", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "KPS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231748", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-09", "submission_number": "K223864", "pathway": "510(k)", "device": "Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial", "company": "Brainlab AG", "panel_lead": "Neurology", "primary_product_code": "HAW", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223864", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-08", "submission_number": "K232686", "pathway": "510(k)", "device": "CorVista® System", "company": "CorVista Health, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "QXX", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232686", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-08", "submission_number": "K231335", "pathway": "510(k)", "device": "Cleerly ISCHEMIA", "company": "Cleerly, Inc", "panel_lead": "Cardiovascular", "primary_product_code": "QXZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231335", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-08", "submission_number": "K223621", "pathway": "510(k)", "device": "DeepXray", "company": "Alpha Intelligence Manifolds, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223621", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-08", "submission_number": "K222921", "pathway": "510(k)", "device": "Minuteful-kidney test", "company": "Healthy.io Ltd.", "panel_lead": "Clinical Chemistry", "primary_product_code": "JIR", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222921", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-07", "submission_number": "K231207", "pathway": "510(k)", "device": "CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)", "company": "Biosense Webster, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "DQK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231207", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-06", "submission_number": "K232482", "pathway": "510(k)", "device": "MAGNETOM Viato.Mobile", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232482", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-09-01", "submission_number": "K223622", "pathway": "510(k)", "device": "FaceHeart Vitals Software Development Kit (FH vitals SDK)", "company": "FaceHeart Corp.", "panel_lead": "Cardiovascular", "primary_product_code": "QME", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223622", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-08-30", "submission_number": "K230355", "pathway": "510(k)", "device": "Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230355", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-08-28", "submission_number": "K223639", "pathway": "510(k)", "device": "VisAble.IO", "company": "TechsoMed", "panel_lead": "Radiology", "primary_product_code": "QTZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223639", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-08-25", "submission_number": "K223180", "pathway": "510(k)", "device": "AIRAscore", "company": "AIRAmed GmbH", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223180", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-08-23", "submission_number": "K230812", "pathway": "510(k)", "device": "Withings Scan Monitor 2.0", "company": "Withings", "panel_lead": "Cardiovascular", "primary_product_code": "DPS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230812", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-08-22", "submission_number": "K230899", "pathway": "510(k)", "device": "qXR-PTX-PE", "company": "Qure.ai Technologies", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230899", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-08-18", "submission_number": "K223539", "pathway": "510(k)", "device": "Dreem 3S", "company": "Beacon Biosignals, Inc.", "panel_lead": "Neurology", "primary_product_code": "OLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223539", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-08-15", "submission_number": "K231094", "pathway": "510(k)", "device": "Annalise Enterprise CTB Triage-OH", "company": "Annalise-AI Pty Ltd", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231094", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-08-03", "submission_number": "K223133", "pathway": "510(k)", "device": "VisiRad XR", "company": "Imidex Inc.", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223133", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-08-03", "submission_number": "DEN230003", "pathway": "De Novo", "device": "Viz HCM", "company": "Viz.ai, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "QXO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230003", "tracker_id": "viz-hcm", "family_evidence_grade": "C" }, { "decision_date": "2023-08-02", "submission_number": "K223553", "pathway": "510(k)", "device": "Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine", "company": "Brainlab AG", "panel_lead": "Neurology", "primary_product_code": "OLO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223553", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-07-27", "submission_number": "K231195", "pathway": "510(k)", "device": "Brainomix 360 Triage ICH", "company": "Brainomix Limited", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231195", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-07-27", "submission_number": "K230074", "pathway": "510(k)", "device": "Rapid Aneurysm Triage and Notification", "company": "iSchemaView Inc.", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230074", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-07-26", "submission_number": "K231572", "pathway": "510(k)", "device": "uMI Panorama", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "KPS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231572", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-07-26", "submission_number": "K231038", "pathway": "510(k)", "device": "Global Hypoperfusion Index (GHI) Algorithm", "company": "Edwards Lifesciences, LLC", "panel_lead": "Cardiovascular", "primary_product_code": "QNL", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231038", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-07-25", "submission_number": "K230913", "pathway": "510(k)", "device": "ANDI", "company": "Imeka Solutions, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230913", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-07-25", "submission_number": "K230365", "pathway": "510(k)", "device": "Sonio Detect", "company": "Sonio", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230365", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-07-25", "submission_number": "K223473", "pathway": "510(k)", "device": "ME-APDS™; MAGENTIQ-COLO™", "company": "Magentiq Eye LTD", "panel_lead": "Gastroenterology-Urology", "primary_product_code": "QNP", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223473", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-07-24", "submission_number": "K223347", "pathway": "510(k)", "device": "UltraSight AI Guidance", "company": "UltraSight Inc.", "panel_lead": "Radiology", "primary_product_code": "QJU", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223347", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-07-21", "submission_number": "K231173", "pathway": "510(k)", "device": "Irregular Rhythm Notification Feature (IRNF)", "company": "Apple Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "QDB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231173", "tracker_id": "apple-irnf", "family_evidence_grade": "B" }, { "decision_date": "2023-07-21", "submission_number": "K230150", "pathway": "510(k)", "device": "OptimMRI", "company": "RebrAIn, SAS", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230150", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-07-21", "submission_number": "K223288", "pathway": "510(k)", "device": "Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI", "company": "Brainlab AG", "panel_lead": "Neurology", "primary_product_code": "HAW", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223288", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-07-20", "submission_number": "K230039", "pathway": "510(k)", "device": "uOmnispace", "company": "Shanghai United Imaging Healthcare Co., Ltd", "panel_lead": "Radiology", "primary_product_code": "QIH", 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"submission_number": "K230273", "pathway": "510(k)", "device": "Saranas Early Bird Bleed Monitoring System", "company": "Saranas Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "QFJ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230273", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-05-25", "submission_number": "K223491", "pathway": "510(k)", "device": "Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite", "company": "GE Medical Systems, LLC", "panel_lead": "Radiology", "primary_product_code": "QBS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223491", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-05-23", "submission_number": "K230096", "pathway": "510(k)", "device": "Genius AI Detection 2.0 with CC-MLO Correlation", "company": "Hologic, Inc.", "panel_lead": "Radiology", "primary_product_code": "QDQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230096", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-05-23", "submission_number": "K223504", "pathway": "510(k)", "device": "Ceribell Status Epilepticus Monitor", "company": "Ceribell, Inc.", "panel_lead": "Neurology", "primary_product_code": "OMB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223504", "tracker_id": "ceribell-se", "family_evidence_grade": "C" }, { "decision_date": "2023-05-19", "submission_number": "K231143", "pathway": "510(k)", "device": "GI Genius System 100 and GI Genius System 200", "company": "Cosmo Artificial Intelligence - AI Ltd", "panel_lead": "Gastroenterology-Urology", "primary_product_code": "QNP", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231143", "tracker_id": "gi-genius", "family_evidence_grade": "A" }, { "decision_date": "2023-05-19", "submission_number": "K212758", "pathway": "510(k)", "device": "Autoplaque", "company": "Cedars-Sinai Medical Center: AIM", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212758", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-05-17", "submission_number": "K222728", "pathway": "510(k)", "device": "Radiation Planning Assistant (RPA)", "company": "University of Texas, MD Anderson Cancer Center", "panel_lead": "Radiology", "primary_product_code": "MUJ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222728", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-05-12", "submission_number": "K231190", "pathway": "510(k)", "device": "EPIQ Series Diagnostic Ultrasound System", "company": "Philips Ultrasound LLC", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": 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"panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230082", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-05-04", "submission_number": "K223771", "pathway": "510(k)", "device": "Lumify Diagnostic Ultrasound System", "company": "Philips Ultrasound", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223771", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-05-02", "submission_number": "K230977", "pathway": "510(k)", "device": "SIS System", "company": "Surgical Information Sciences, Inc.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230977", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-05-02", "submission_number": "K230292", "pathway": "510(k)", "device": "Samsung ECG Monitor Application with Irregular Heart Rhythm Notification", "company": "Samsung Electronics Co., Ltd", "panel_lead": "Cardiovascular", "primary_product_code": "QDA", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230292", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-04-28", "submission_number": "P210011", "pathway": "PMA", "device": "xT CDx", "company": "Tempus Labs, Inc.", "panel_lead": "Pathology", "primary_product_code": "PQP", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210011", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-04-27", "submission_number": "K223734", "pathway": "510(k)", "device": "ENT EM", "company": "Brainlab AG", "panel_lead": "Neurology", "primary_product_code": "PGW", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223734", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-04-27", "submission_number": "K223212", "pathway": "510(k)", "device": "Precision DL", "company": "GE Healthcare", "panel_lead": "Radiology", "primary_product_code": "KPS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223212", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-04-26", "submission_number": "K230553", "pathway": "510(k)", "device": "LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application", "company": "Medtronic, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "MXD", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230553", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-04-26", "submission_number": "K230552", "pathway": "510(k)", "device": 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"submission_number": "K230084", "pathway": "510(k)", "device": "HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System", "company": "Samsung Medison CO., LTD.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230084", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-04-21", "submission_number": "K223501", "pathway": "510(k)", "device": "ViewFinder Software Version 1.1", "company": "Elaitra Ltd", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223501", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-04-20", "submission_number": "K230807", "pathway": "510(k)", "device": "Deep Learning Image Reconstruction", "company": "GE Healthcare Japan Corporation", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230807", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-04-20", "submission_number": "K223287", "pathway": "510(k)", "device": "Velacur", "company": "Sonic Incytes", "panel_lead": "Radiology", "primary_product_code": "IYO", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223287", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-04-19", "submission_number": "K230023", "pathway": "510(k)", "device": "ART-Plan", "company": "Therapanacea SAS", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230023", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2023-04-19", "submission_number": "K223552", "pathway": "510(k)", "device": "Brainlab Elements – Trajectory Planning (2.6), Elements 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"pathway": "510(k)", "device": "SomnoMetry", "company": "Neumetry Medical Inc", "panel_lead": "Neurology", "primary_product_code": "OLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221179", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-09-20", "submission_number": "K213353", "pathway": "510(k)", "device": "Aorta-CAD", "company": "Imagen Technologies, Inc", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213353", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-09-13", "submission_number": "K221733", "pathway": "510(k)", "device": "MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221733", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-09-12", "submission_number": "K221456", "pathway": "510(k)", "device": "Rapid ICH", "company": "iSchemaView Inc.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221456", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-09-12", "submission_number": "K220986", "pathway": "510(k)", "device": "Aquilion Precision (TSX-304A/4) V10.10 with AiCE", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220986", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-09-08", "submission_number": "K222076", "pathway": "510(k)", "device": "EFAI ChestSuite XR Pleural Effusion Assessment System", "company": "Ever Fortune.AI Co., 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"tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-07-18", "submission_number": "K221148", "pathway": "510(k)", "device": "Vivid iq", "company": "GE Medical Systems Ultrasound & Primary Care Diagnostics LLC", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221148", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-07-18", "submission_number": "K221147", "pathway": "510(k)", "device": "Vivid T8, Vivid T9", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics,", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221147", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-07-15", "submission_number": "K220619", "pathway": "510(k)", "device": "Vivid S60N, Vivid S70N", "company": "GE Medical Systems 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"submission_number": "K220800", "pathway": "510(k)", "device": "Venue Go", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220800", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-06-17", "submission_number": "K221463", "pathway": "510(k)", "device": "ElucidVivo A.3", "company": "Elucid Bioimaging Inc.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221463", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-06-17", "submission_number": "K220813", "pathway": "510(k)", "device": "ART-PLAN", "company": "TheraPanacea", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220813", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-06-17", "submission_number": "K213037", "pathway": "510(k)", "device": "IDx-DR v2.3", "company": "Digital Diagnostics Inc.", "panel_lead": "Ophthalmic", "primary_product_code": "PIB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213037", "tracker_id": "idx-dr", "family_evidence_grade": "A" }, { "decision_date": "2022-06-16", "submission_number": "K213504", "pathway": "510(k)", "device": "Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213504", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-06-10", "submission_number": "K221393", "pathway": "510(k)", "device": "Swoop Portable MR Imaging System", "company": "Hyperfine, Inc.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221393", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-06-08", "submission_number": "K213882", "pathway": "510(k)", "device": "EarliPoint System", "company": "EarliTec Diagnostics, Inc.", "panel_lead": "Neurology", "primary_product_code": "QPF", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213882", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-06-08", "submission_number": "K213717", "pathway": "510(k)", "device": "AIR Recon DL", "company": "GE Medical Systems,LLC (GE Healthcare)", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213717", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-06-06", "submission_number": "K220358", "pathway": "510(k)", "device": "Voluson Expert 22, Voluson Expert 20, Voluson Expert 18", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics,", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220358", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-06-03", "submission_number": "K221314", "pathway": "510(k)", "device": "BriefCase", "company": "Aidoc Medical, Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221314", "tracker_id": "aidoc-briefcase-ich", "family_evidence_grade": "C" }, { "decision_date": "2022-06-03", "submission_number": "K213971", "pathway": "510(k)", "device": "Atrial Fibrillation History Feature", "company": "Apple Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "QDB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213971", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-06-02", "submission_number": "K220164", "pathway": "510(k)", "device": "Rayvolve", "company": "AZmed SAS", "panel_lead": "Radiology", "primary_product_code": "QBS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220164", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-05-31", "submission_number": "K221248", "pathway": "510(k)", "device": "Rapid LVO", "company": "iSchemaView Inc.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221248", "tracker_id": "rapid-lvo", "family_evidence_grade": "C" }, { "decision_date": "2022-05-31", "submission_number": "K220766", "pathway": "510(k)", "device": "eMurmur Heart AI", "company": "CSD Labs GmbH", "panel_lead": 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"submission_number": "K212960", "pathway": "510(k)", "device": "Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212960", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-03-22", "submission_number": "K200828", "pathway": "510(k)", "device": "Athelas Home", "company": "Athelas Inc.", "panel_lead": "Hematology", "primary_product_code": "GKZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200828", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-03-21", "submission_number": "K213721", "pathway": "510(k)", "device": "BriefCase", "company": "Aidoc Medical, Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": 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"panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203744", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-03-11", "submission_number": "K213725", "pathway": "510(k)", "device": "CardIQ Suite", "company": "GE Medical Systems SCS", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213725", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-03-10", "submission_number": "K213566", "pathway": "510(k)", "device": "ClearRead Xray Pneumothorax", "company": "Riverain Technologies, Inc.", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213566", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-03-04", "submission_number": "K210365", "pathway": "510(k)", "device": "Second Opinion", "company": "Pearl Inc.", "panel_lead": "Radiology", "primary_product_code": "MYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210365", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-03-01", "submission_number": "K212365", "pathway": "510(k)", "device": "BoneView", "company": "Gleamer", "panel_lead": "Radiology", "primary_product_code": "QBS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212365", "tracker_id": "gleamer-boneview", "family_evidence_grade": "C" }, { "decision_date": "2022-02-25", "submission_number": "K213693", "pathway": "510(k)", "device": "MAGNETOM Vida with syngo MR XA50A", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213693", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-02-24", "submission_number": "K213941", "pathway": "510(k)", "device": "Annalise Enterprise CXR Triage Pneumothorax", "company": "Annalise-AI", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213941", "tracker_id": "annalise-cxr", "family_evidence_grade": "C" }, { "decision_date": "2022-02-18", "submission_number": "K213999", "pathway": "510(k)", "device": "Deep Learning Image Reconstruction", "company": "GE Medical Systems, LLC.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213999", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-02-18", "submission_number": "K213319", "pathway": "510(k)", "device": "Viz ANEURYSM, Viz ANX", "company": "Viz.ai, Inc.", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213319", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-02-17", "submission_number": "K213689", "pathway": "510(k)", "device": "Voluson P6, Voluson P8", "company": "GE Healthcare", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213689", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-02-11", "submission_number": "K213603", "pathway": "510(k)", "device": "SIGNA Artist Evo", "company": "GE Healthcare(Tianjin) Company Limited", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213603", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-02-08", "submission_number": "K213165", "pathway": "510(k)", "device": "Rapid", "company": "iSchema View Inc.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213165", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-02-04", "submission_number": "K213938", "pathway": "510(k)", "device": "Revolution Ascend", "company": "GE Healthcare Japan Corporation", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213938", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-02-04", "submission_number": "K212654", "pathway": "510(k)", "device": "Micro C Medical Imaging System, M01", "company": "OXOS Medical, Inc.", "panel_lead": "Radiology", "primary_product_code": "IZL", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212654", "tracker_id": "", "family_evidence_grade": "not graded" }, { 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"IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212333", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-01-20", "submission_number": "K214019", "pathway": "510(k)", "device": "syngo.CT Extended Functionality", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K214019", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-01-20", "submission_number": "K213668", "pathway": "510(k)", "device": "SIGNA Hero", "company": "GE Healthcare (GE Medical Systems, LLC)", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213668", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2022-01-19", "submission_number": "K212012", "pathway": "510(k)", 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"not graded" }, { "decision_date": "2021-12-22", "submission_number": "K202404", "pathway": "510(k)", "device": "BoneMRI", "company": "MRIguidance B.V", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202404", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-12-21", "submission_number": "K212690", "pathway": "510(k)", "device": "qXR-BT", "company": "Qure.ai Technologies", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212690", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-12-21", "submission_number": "K210670", "pathway": "510(k)", "device": "BU-CAD", "company": "TaiHao Medical Inc.", "panel_lead": "Radiology", "primary_product_code": "QDQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210670", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-12-20", "submission_number": "K213275", "pathway": "510(k)", "device": "EchoGo Core (2.0)", "company": "Ultromics Limited", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213275", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-12-16", "submission_number": "K213628", "pathway": "510(k)", "device": "VBrain", "company": "Vysioneer Inc.", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213628", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-12-16", "submission_number": "K212616", "pathway": "510(k)", "device": "Koios DS", "company": "Koios Medical, Inc.", "panel_lead": "Radiology", "primary_product_code": "POK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212616", "tracker_id": "koios-ds", "family_evidence_grade": "C" }, { "decision_date": "2021-12-15", "submission_number": "K213155", "pathway": "510(k)", "device": "RT-Mind-AI", "company": "MedMind Technology Co., Ltd.", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213155", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-12-15", "submission_number": "K211803", "pathway": "510(k)", "device": "HealthPPT", "company": "Zebra Medical Vision Ltd.", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211803", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-12-09", "submission_number": "K212466", "pathway": "510(k)", "device": "LVivo Seamless", "company": "DiA Imaging Analysis 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"submission_number": "K212219", "pathway": "510(k)", "device": "AHI System", "company": "Fifth Eye Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "QNV", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212219", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-12-01", "submission_number": "K213305", "pathway": "510(k)", "device": "Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213305", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-11-26", "submission_number": "K211541", "pathway": "510(k)", "device": "MammoScreen 2.0", "company": "Therapixel", "panel_lead": "Radiology", "primary_product_code": "QDQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211541", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-11-19", "submission_number": "K211326", "pathway": "510(k)", "device": "EndoScreener", "company": "Chengdu Wision Medical Device Co., LTD.", "panel_lead": "Gastroenterology-Urology", "primary_product_code": "QNP", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211326", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-11-19", "submission_number": "K210831", "pathway": "510(k)", "device": "OnQ Neuro", "company": "CorTechs Labs, Inc", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210831", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-11-17", "submission_number": "K212456", "pathway": "510(k)", "device": "Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System", "company": "Hyperfine, Inc.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212456", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-11-17", "submission_number": "K212336", "pathway": "510(k)", "device": "Soteria.AI", "company": "Omega Medical Imaging, LLC", "panel_lead": "Radiology", "primary_product_code": "OWB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212336", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-11-17", "submission_number": "K211678", "pathway": "510(k)", "device": "Lunit INSIGHT MMG", "company": "Lunit Inc.", "panel_lead": "Radiology", "primary_product_code": "QDQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211678", "tracker_id": "lunit-insight-mmg", "family_evidence_grade": "B" }, { "decision_date": "2021-11-16", "submission_number": "K212265", "pathway": "510(k)", "device": "TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System", "company": "Shenzhen Mindray Bio-Medical Electronics Co.,LTD", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212265", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-11-15", "submission_number": "K213436", "pathway": "510(k)", "device": "Clarius Ultrasound Scanner", "company": "Clarius Mobile Health Corp.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213436", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-11-10", "submission_number": "K211733", "pathway": "510(k)", "device": "Lunit INSIGHT CXR Triage", "company": "Lunit Inc.", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211733", "tracker_id": "lunit-insight-cxr", "family_evidence_grade": "B" }, { "decision_date": "2021-11-03", "submission_number": "K210543", "pathway": "510(k)", "device": "IM007", "company": "Implicity, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "DQK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210543", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-10-29", "submission_number": "K211161", "pathway": "510(k)", "device": "Critical Care Suite with Endotracheal Tube Positing AI algorithm", "company": "GE Medical Systems, LLC", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211161", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-10-25", "submission_number": "K212218", "pathway": "510(k)", "device": "Advanced Algorithms for Treatment Management Applications (AATMA)", "company": "Elekta Solutions AB", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212218", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-10-22", "submission_number": "K212516", "pathway": "510(k)", "device": "IRNF App", "company": "Apple Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "QDB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212516", "tracker_id": "apple-irnf", "family_evidence_grade": "B" }, { "decision_date": "2021-10-22", "submission_number": "K210807", "pathway": "510(k)", "device": "FlightPlan for Liver", "company": "GE Medical Systems SCS", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210807", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-10-20", "submission_number": "K210632", "pathway": "510(k)", "device": "Contour ProtegeAI", "company": "MIM Software Inc.", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210632", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-10-14", "submission_number": "K212261", "pathway": "510(k)", "device": "StrokeSENS LVO", "company": "Circle Neurovascular Imaging, Inc", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212261", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-10-14", "submission_number": "K210999", "pathway": "510(k)", "device": "SwiftMR", "company": "AIRS Medical Inc.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210999", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-10-12", "submission_number": "K212116", "pathway": "510(k)", "device": "VBrain-OAR", "company": "Vysioneer Inc.", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212116", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-10-02", "submission_number": "K202927", "pathway": "510(k)", "device": "EYE-SYNC", "company": "SyncThink, Inc.", "panel_lead": "Neurology", "primary_product_code": "QEA", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202927", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-09-28", "submission_number": "K211964", "pathway": "510(k)", "device": "SubtlePET", "company": "Subtle Medical, Inc.", "panel_lead": "Radiology", "primary_product_code": "KPS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K211964", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-09-24", "submission_number": "K212704", "pathway": "510(k)", "device": "Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System", "company": "Philips Medical Systems", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212704", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-09-21", "submission_number": "DEN200080", "pathway": "De Novo", "device": "Paige Prostate", "company": "Paige.AI", "panel_lead": "Pathology", "primary_product_code": "QPN", "fda_url": 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Ltd.", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203502", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-04-23", "submission_number": "K203314", "pathway": "510(k)", "device": "Cartesion Prime (PCD-1000A/3) V10.8", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "KPS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203314", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-04-21", "submission_number": "K210556", "pathway": "510(k)", "device": "Preview Shoulder", "company": "Genesis Software Innovations", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210556", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-04-20", "submission_number": "K203610", "pathway": "510(k)", "device": "Automatic Anatomy Recognition (AAR)", "company": "Quantitative Radiology Solutions, LLC", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203610", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-04-19", "submission_number": "K203469", "pathway": "510(k)", "device": "AI Segmentation", "company": "Varian Medical Systems, Inc.", "panel_lead": "Radiology", "primary_product_code": "MUJ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203469", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-04-16", "submission_number": "K203517", "pathway": "510(k)", "device": "Saige-Q", "company": "DeepHealth, Inc.", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203517", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-04-14", "submission_number": "K202992", "pathway": "510(k)", "device": "BriefCase, RIB Fractures Triage (RibFx)", "company": "Aidoc Medical, Ltd.", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202992", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-04-09", "submission_number": "DEN200055", "pathway": "De Novo", "device": "GI Genius", "company": "Cosmo Artificial Intelligence - AI, LTD", "panel_lead": "Gastroenterology-Urology", "primary_product_code": "QNP", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200055", "tracker_id": "gi-genius", "family_evidence_grade": "A" }, { "decision_date": "2021-04-02", "submission_number": "K202928", "pathway": "510(k)", "device": "DV. Target", "company": "Deepvoxel INC", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202928", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-04-02", "submission_number": "K202441", "pathway": "510(k)", "device": "Eclipse II with Smart Noise Cancellation", "company": "Carestream Health, Inc.", "panel_lead": "Radiology", "primary_product_code": "MQB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202441", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-04-01", "submission_number": "DEN200038", "pathway": "De Novo", "device": "Gili Pro BioSensor (also known as “Gili BioSensor System”)", "company": "ContinUse Biometrics Ltd.", "panel_lead": "Cardiovascular", "primary_product_code": "QOK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200038", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-03-31", "submission_number": "K210071", "pathway": "510(k)", "device": "SIS System (Version 5.1.0)", "company": "Surgical Information Sciences, Inc.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210071", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-03-31", "submission_number": "K203443", "pathway": "510(k)", "device": "MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203443", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-03-31", "submission_number": "K203258", "pathway": "510(k)", "device": "syngo.CT Lung CAD", "company": "Siemens Healthcare GmbH", "panel_lead": "Radiology", "primary_product_code": "OEB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203258", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-03-26", "submission_number": "DEN200019", "pathway": "De Novo", "device": "Oxehealth Vital Signs", "company": "Oxehealth Limited", "panel_lead": "Cardiovascular", "primary_product_code": "QME", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200019", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-03-24", "submission_number": "K203225", "pathway": "510(k)", "device": "Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203225", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-03-23", "submission_number": "K210209", "pathway": "510(k)", "device": "Viz ICH", "company": "Viz.ai, Inc.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210209", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-03-19", "submission_number": "K203235", "pathway": "510(k)", "device": "VBrain", "company": "Vysioneer Inc.", "panel_lead": "Radiology", "primary_product_code": "QKB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203235", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-03-12", "submission_number": "K203822", "pathway": "510(k)", "device": "ProFound AI Software V3.0", "company": "iCAD Inc.", "panel_lead": "Radiology", "primary_product_code": "QDQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203822", "tracker_id": "icad-dbt", "family_evidence_grade": "C" }, { "decision_date": "2021-03-12", "submission_number": "K202284", "pathway": "510(k)", "device": "Oncospace", "company": "Oncospace, Inc.", "panel_lead": "Radiology", "primary_product_code": "MUJ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202284", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-03-09", "submission_number": "K203256", "pathway": "510(k)", "device": "Imbio RV/LV Software", "company": "Imbio, LLC", "panel_lead": "Radiology", "primary_product_code": "QIH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203256", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-03-05", "submission_number": "K202300", "pathway": "510(k)", "device": "Optellum Virtual Nodule Clinic, Optellum software, Optellum platform", "company": "Optellum Ltd", "panel_lead": "Radiology", "primary_product_code": "POK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202300", "tracker_id": "optellum-vnc", "family_evidence_grade": "C" }, { "decision_date": "2021-03-04", "submission_number": "K203323", "pathway": "510(k)", "device": "Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203323", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-03-02", "submission_number": "K203617", "pathway": "510(k)", "device": "MaxFOV 2", "company": "GE Medical Systems, LLC.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203617", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-03-01", "submission_number": "DEN200022", "pathway": "De Novo", "device": "Analytic for Hemodynamic Instability (AHI)", "company": "Fifth Eye Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "QNV", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200022", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-02-26", "submission_number": "K203182", "pathway": "510(k)", "device": "SubtleMR", "company": "Subtle Medical, Inc.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K203182", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2021-02-25", "submission_number": "K203578", "pathway": "510(k)", "device": "OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System", "company": "Perimeter Medical Imaging AI, Inc.", "panel_lead": "Radiology", 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"tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-09-11", "submission_number": "K183370", "pathway": "510(k)", "device": "PeraMobile and PeraWatch", "company": "PeraHealth, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "MWI", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183370", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-09-10", "submission_number": "K183268", "pathway": "510(k)", "device": "AI-Rad Companion (Cardiovascular)", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183268", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-09-04", "submission_number": "K191179", "pathway": "510(k)", "device": "Myo Plus", "company": "Otto Bock Healthcare Products GmbH", "panel_lead": "Neurology", "primary_product_code": "GXY", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191179", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-08-29", "submission_number": "K192107", "pathway": "510(k)", "device": "Clarius Ultrasound Scanner", "company": "Clarius Mobile Health Corp.", "panel_lead": "Radiology", "primary_product_code": "IYN", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192107", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-08-29", "submission_number": "K183489", "pathway": "510(k)", "device": "D2P", "company": "3D Systems, Inc.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183489", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-08-23", "submission_number": "K190593", "pathway": "510(k)", "device": "Zio XT ECG Monitoring System, Zio AT ECG Monitoring System", "company": "iRhythm Technologies, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "DQK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190593", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-08-15", "submission_number": "K190925", "pathway": "510(k)", "device": "HeartFlow FFRct Analysis", "company": "HeartFlow, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "PJA", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190925", "tracker_id": "heartflow-ffrct", "family_evidence_grade": "A" }, { "decision_date": "2019-08-15", "submission_number": "K183282", "pathway": "510(k)", "device": "Biovitals Analytics Engine", "company": "Biofourmis Singapore Pte. Ltd", "panel_lead": "Cardiovascular", "primary_product_code": "PLB", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183282", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-08-12", "submission_number": "K183182", "pathway": "510(k)", "device": "Critical Care Suite", "company": "GE Medical Systems, LLC.", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183182", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-08-05", "submission_number": "K191262", "pathway": "510(k)", "device": "aBSI", "company": "EXINI Diagnostics AB", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191262", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-07-31", "submission_number": "K191183", "pathway": "510(k)", "device": "EyeBOX", "company": "Oculogica, Inc.", "panel_lead": "Neurology", "primary_product_code": "QEA", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191183", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-07-26", "submission_number": "K183271", "pathway": "510(k)", "device": "AI-Rad Companion (Pulmonary)", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183271", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-07-26", "submission_number": "K182384", "pathway": "510(k)", "device": "ACR LAB Urine Analysis Test System", "company": "Healthy.io Ltd", "panel_lead": "Clinical Chemistry", "primary_product_code": "JFY", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182384", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-07-19", "submission_number": "K182798", "pathway": "510(k)", "device": "KIDScore D3", "company": "Vitrolife A/S", "panel_lead": "Obstetrics and Gynecology", "primary_product_code": "PBH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182798", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-07-18", "submission_number": "K191370", "pathway": "510(k)", "device": "DreaMed Advisor Pro", "company": "DreaMed Diabetes Ltd", "panel_lead": "Clinical Chemistry", "primary_product_code": "QCC", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191370", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-07-12", "submission_number": "K191585", "pathway": "510(k)", "device": "iNtuition-Structural Heart Module", "company": "TeraRecon Inc.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191585", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-07-10", "submission_number": "K183322", "pathway": "510(k)", "device": "physIQ Heart Rhythm and Respiratory Module", "company": "physIQ, Inc", "panel_lead": "Cardiovascular", "primary_product_code": "DPS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183322", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-07-10", "submission_number": "K182875", "pathway": "510(k)", "device": "DeepCT", "company": "Deep01 Limited", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182875", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-07-08", "submission_number": "K191384", "pathway": "510(k)", "device": "RayCare 2.3", "company": "RaySearch Laboratories AB (publ)", "panel_lead": "Radiology", "primary_product_code": "MUJ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191384", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-07-05", "submission_number": "K182901", "pathway": "510(k)", "device": "Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182901", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-07-03", "submission_number": "K190442", "pathway": "510(k)", "device": "Koios DS for Breast", "company": "Koios Medical, Inc.", "panel_lead": "Radiology", "primary_product_code": "POK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190442", "tracker_id": "koios-ds", "family_evidence_grade": "C" }, { "decision_date": "2019-06-27", "submission_number": "K190017", "pathway": "510(k)", "device": "LiverMultiScan (LMSv3)", "company": "Perspectum Diagnostics Ltd", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190017", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-06-25", "submission_number": "K191194", "pathway": "510(k)", "device": "CLARUS", "company": "Carl Zeiss Meditec, Inc", "panel_lead": "Ophthalmic", "primary_product_code": "QER", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191194", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-06-19", "submission_number": "K190387", "pathway": "510(k)", "device": "RayStation", "company": "RaySearch Laboratories AB (publ)", "panel_lead": "Radiology", "primary_product_code": "MUJ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190387", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-06-13", "submission_number": "K190424", "pathway": "510(k)", "device": "HealthICH", "company": "Zebra Medical Vision Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190424", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-06-13", "submission_number": "K183460", "pathway": "510(k)", "device": "ClariCT.AI", "company": "ClariPI Inc.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183460", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-06-12", "submission_number": "K183046", "pathway": "510(k)", "device": "Aquilion ONE (TSX-305A/6) V8.9 with AiCE", "company": "Canon Medical Systems Corporation", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183046", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-05-31", "submission_number": "K190896", "pathway": "510(k)", "device": "BriefCase", "company": "Aidoc Medical, Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190896", "tracker_id": "aidoc-briefcase-ich", "family_evidence_grade": "C" }, { "decision_date": "2019-05-24", "submission_number": "K191083", "pathway": "510(k)", "device": "COMPLETE CONTROL System Gen2", "company": "Coapt, LLC", "panel_lead": "Neurology", "primary_product_code": "GXY", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191083", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-05-21", "submission_number": "K183646", "pathway": "510(k)", "device": "Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure", "company": "Edwards Lifeciences, LLC", "panel_lead": "Cardiovascular", "primary_product_code": "QAQ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183646", "tracker_id": "edwards-hpi", "family_evidence_grade": "A" }, { "decision_date": "2019-05-15", "submission_number": "K183648", "pathway": "510(k)", "device": "APAS Independence with Urine Analysis Module", "company": "Clever Culture Systems AG", "panel_lead": "Microbiology", "primary_product_code": "PPU", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183648", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-05-13", "submission_number": "K190764", "pathway": "510(k)", "device": "SurgicalAR", "company": "MEDIVIS, Inc.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190764", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-05-06", "submission_number": "K190362", "pathway": "510(k)", "device": "HealthPNX", "company": "Zebra Medical Vision Ltd.", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190362", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-04-22", "submission_number": "K182513", "pathway": "510(k)", "device": "FluChip-8G Influenza A+B Assay", "company": "InDevR, Inc.", "panel_lead": "Microbiology", "primary_product_code": "OZE", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182513", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-04-18", "submission_number": "K183593", "pathway": "510(k)", "device": "Lung Vision System", "company": "Body Vision Medical Ltd.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183593", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-04-17", "submission_number": "K181988", "pathway": "510(k)", "device": "eMurmur ID", "company": "CSD Labs GmbH", "panel_lead": "Cardiovascular", "primary_product_code": "DQD", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181988", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-04-15", "submission_number": "K190072", "pathway": "510(k)", "device": "BriefCase", "company": "Aidoc Medical, Ltd.", "panel_lead": "Radiology", "primary_product_code": "QAS", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190072", "tracker_id": "aidoc-briefcase-ich", "family_evidence_grade": "C" }, { "decision_date": "2019-04-12", "submission_number": "K183202", "pathway": "510(k)", "device": "Deep Learning Image Reconstruction", "company": "GE Medical Systems, LLC.", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183202", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-04-08", "submission_number": "K183204", "pathway": "510(k)", "device": "Bone VCAR (BVCAR)", "company": "GE Medical Systems SCS", "panel_lead": "Radiology", "primary_product_code": "JAK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183204", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-03-29", "submission_number": "K181352", "pathway": "510(k)", "device": "Loop System", "company": "Spry Health, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "DQA", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181352", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-03-19", "submission_number": "K183019", "pathway": "510(k)", "device": "SIS Software version 3.3.0", "company": "Surgical Information Sciences, Inc.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183019", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-03-11", "submission_number": "K181823", "pathway": "510(k)", "device": "KardiaAI", "company": "AliveCor, Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "DQK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181823", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-03-08", "submission_number": "K183285", "pathway": "510(k)", "device": "cmTriage", "company": "CureMetrix, Inc", "panel_lead": "Radiology", "primary_product_code": "QFM", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183285", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-03-07", "submission_number": "K182344", "pathway": "510(k)", "device": "RhythmAnalytics", "company": "Biofourmis Singapore Pte. Ltd.", "panel_lead": "Cardiovascular", "primary_product_code": "DQK", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182344", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-02-16", "submission_number": "K183704", "pathway": "510(k)", "device": "RX-1 Rhythm Express Remote Cardiac Monitoring System", "company": "VivaQuant Inc.", "panel_lead": "Cardiovascular", "primary_product_code": "DXH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183704", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-02-04", "submission_number": "K181916", "pathway": "510(k)", "device": "d-Nav System", "company": "Hygieia, Inc", "panel_lead": "Anesthesiology", "primary_product_code": "NDC", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181916", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-02-01", "submission_number": "K183272", "pathway": "510(k)", "device": "AI Rad Companion (Engine)", "company": "Siemens Medical Solutions USA, Inc.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183272", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-01-18", "submission_number": "K183231", "pathway": "510(k)", "device": "SIGNA Premier", "company": "GE Medical Systems, LLC", "panel_lead": "Radiology", "primary_product_code": "LNH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183231", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-01-17", "submission_number": "K182456", "pathway": "510(k)", "device": "Study Watch", "company": "Verily Life Sciences LLC", "panel_lead": "Cardiovascular", "primary_product_code": "DXH", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182456", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2019-01-09", "submission_number": "K183133", "pathway": "510(k)", "device": "MRCP+ v1.0", "company": "Perspectum Diagnostics Ltd", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183133", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2018-12-28", "submission_number": "K180867", "pathway": "510(k)", "device": "AmCAD-UO", "company": "AmCad BioMed Corporation", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K180867", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2018-12-28", "submission_number": "DEN170091", "pathway": "De Novo", "device": "EyeBOX", "company": "Oculogica, Inc.", "panel_lead": "Neurology", "primary_product_code": "QEA", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170091", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2018-12-27", "submission_number": "K182564", "pathway": "510(k)", "device": "Quantib ND", "company": "Quantib BV", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182564", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2018-12-27", "submission_number": "K182130", "pathway": "510(k)", "device": "iSchemaView RAPID", "company": "iSchemaView, Inc.", "panel_lead": "Radiology", "primary_product_code": "LLZ", "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182130", "tracker_id": "", "family_evidence_grade": "not graded" }, { "decision_date": "2018-12-21", "submission_number": "K183012", "pathway": "510(k)", 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