510(k) Report

Devices descending from K122429

16 later devices reach Vessel Analysis and Autoplaque for Ors Visual through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+1K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+1K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+1K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+1K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+1K190868Cleerly LabsCleerly, Inc.20197—
+2K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+2K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+2K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+2K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+3K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+3K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+3K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+3K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+4K261210Cleerly PlaqueCleerly, Inc.20260—
+4K260588Cleerly LABSCleerly, Inc.20260—