510(k) Report

Devices descending from K060779

55 later devices reach Advance Vessel Analysis II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200626VesselIQ XpressGE Medical Systems SCS20210—
+1K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+1K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+1K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+1K061370Cardiq FusionGE Healthcare200651—
+2K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+2K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+2K240786AutoChamberHeartLung Corporation20241—
+2K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+2K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+2K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+2K190868Cleerly LabsCleerly, Inc.20197—
+2K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+2K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+2K113543ONDEMAND3DCybermed, Inc.20119—
+2K103465Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc.201120—
+3K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+3K252029AI-CVDHeartLung Corporation20250—
+3K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+3K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+3K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+3K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+3K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+3K152746Ez3D PlusEwoosoft Co., Ltd.20161—
+3K132773Sidexis 4Sirona Dental Systems GmbH20131—
+3K131616EZ3D-I, E3Ewoosoft Co., Ltd.20134—
+3K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+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—
+4K250755DS Core DiagnosisDentsply Sirona, Inc.20250—
+4K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+4K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+4K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+4K160666Dentiq3D3D Industrial Imaging Co., Ltd.20160—
+4K150761Ez3D-i/E3Ewoosoft Co., Ltd.20153—
+4K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+5K261210Cleerly PlaqueCleerly, Inc.20260—
+5K260588Cleerly LABSCleerly, Inc.20260—
+5K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+5K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+5K161246Ez3D-i / E3Ewoosoft Co., Ltd.20162—
+6K220039AutoSegAi Medic, Inc.20221—
+6K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+6K220727inHEART MODELSInheart, Sas20221—
+6K163539Ez3D-i / E3Ewoosoft Co., Ltd.20161—
+7K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+7K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+7K231683inHEART ModelsInheart, Sas20240—
+7K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+7K173863Ez3D-i /E3Ewoosoft Co., Ltd.20180—
+8K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+8K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+9K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+9K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—