510(k) Report

Devices descending from K092747

19 later devices reach Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240786AutoChamberHeartLung Corporation20241—
+1K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+2K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+2K252029AI-CVDHeartLung Corporation20250—
+2K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+2K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+2K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+2K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+2K190868Cleerly LabsCleerly, Inc.20197—
+3K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+3K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+3K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+3K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+4K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+4K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+4K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+4K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+5K261210Cleerly PlaqueCleerly, Inc.20260—
+5K260588Cleerly LABSCleerly, Inc.20260—