510(k) Report

Devices descending from K071331

82 later devices reach Vitrea Version 4.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163071vascuCAPElucid Bioimaging, Inc.20173—
+1K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+1K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—
+1K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+1K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+1K121213VitreaadvancedVital Images, Inc.201281
+1K121023Spectrum V.0Intrinsic Medical Imaging20120—
+1K120207VISIAMeVis Medical Solutions AG20120—
+1K120484Visia OncologyMeVis Medical Solutions AG20128—
+1K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+1K083691BonevueMicromri, Inc.20090—
+1K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+1K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+1K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+1K072821Vitrea 4DCTVital Images, Inc.2008171
+2K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+2K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+2K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+2K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+2K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+2K190868Cleerly LabsCleerly, Inc.20197—
+2K183012vascuCAPElucid Bioimaging, Inc.20182—
+2K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+2K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+2K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+2K153289HealthmyneHealthmyne, Inc.20160—
+2K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+2K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+2K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+2K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+2K132853NovapacsNovarad Corp.201462
+2K141329RadspaTelerad Tech Private Limited20140—
+2K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+2K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+3K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+3K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+3K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+3K240620Cube NavigatorMedical Templates AG20240—
+3K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+3K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+3K191530StoneCheckerImaging Biometrics, LLC20191—
+3K180867AmCAD-UOAmcad Biomed Corporation20180—
+3K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+3K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+3K181892Ziostation2Ziosoft, Inc.20181—
+3K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+3K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+3K160371NovaPACSNovarad Corporation20165—
+3K151988Visible Patient SuiteVisible Patient, Sas20154—
+3K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+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—
+4K244012Mosaic (V1.0.1)Navier Medical20250—
+4K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+4K212896Visible Patient SuiteVisible Patient, Sas20213—
+4K202084DeepLook PRECISEDeeplook, Inc.20210—
+4K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+4K200315Ziostation2Ziosoft, Inc.20200—
+4K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+4K171754NovaPACSNovarad Corporation201741
+5K261210Cleerly PlaqueCleerly, Inc.20260—
+5K260588Cleerly LABSCleerly, Inc.20260—
+5K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+5K233457RUSHutom, Inc.20240—
+5K231662Aid-UIaid20241—
+5K221796Cyware 4H and Cysart 4HAbys Medical20221—
+5K220039AutoSegAi Medic, Inc.20221—
+5K220727inHEART MODELSInheart, Sas20221—
+5K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+6K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+6K250039HPACSHealthhub20250—
+6K243069Lumys (V1)Intradys20250—
+6K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+6K231683inHEART ModelsInheart, Sas20240—
+6K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+7K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+7K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+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—