510(k) Report

Devices descending from K061624

111 later devices reach Vitrea, Version 3.9 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113620Myrian 1.11Intrasense20126—
+1K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+1K091001Myrian 1.4Intrasense20097—
+1K072242Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd.20075—
+1K071362Vital Connect 4.1Vital Images, Inc.2007113
+1K071331Vitrea Version 4.0Vital Images, Inc.2007821
+1K071000MyrianIntrasense20078—
+1K063548Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd.20076—
+1K062328Vitreaaccess, Version 1.0Vital Images, Inc.20060—
+2K240786AutoChamberHeartLung Corporation20241—
+2K163071vascuCAPElucid Bioimaging, Inc.20173—
+2K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+2K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+2K150738VitreaViewVital Images, Inc.20158—
+2K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—
+2K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+2K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+2K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+2K121213VitreaadvancedVital Images, Inc.201281
+2K121023Spectrum V.0Intrinsic Medical Imaging20120—
+2K120207VISIAMeVis Medical Solutions AG20120—
+2K120484Visia OncologyMeVis Medical Solutions AG20128—
+2K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+2K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+2K083691BonevueMicromri, Inc.20090—
+2K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+2K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+2K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+2K072821Vitrea 4DCTVital Images, Inc.2008171
+3K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+3K252029AI-CVDHeartLung Corporation20250—
+3K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+3K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+3K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+3K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+3K211655aPROMISEExini Diagnostics AB20211—
+3K190868Cleerly LabsCleerly, Inc.20197—
+3K183012vascuCAPElucid Bioimaging, Inc.20182—
+3K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+3K181892Ziostation2Ziosoft, Inc.20181—
+3K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+3K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+3K163232Vitrea ViewVital Images, Inc.20177—
+3K153289HealthmyneHealthmyne, Inc.20160—
+3K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+3K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+3K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+3K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+3K132853NovapacsNovarad Corp.201462
+3K141329RadspaTelerad Tech Private Limited20140—
+3K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+3K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+3K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+4K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+4K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+4K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+4K240620Cube NavigatorMedical Templates AG20240—
+4K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+4K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+4K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+4K220590aPROMISE XExini Diagnostics AB20220—
+4K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+4K200315Ziostation2Ziosoft, Inc.20200—
+4K191530StoneCheckerImaging Biometrics, LLC20191—
+4K190764SurgicalARMedivis, Inc.20196—
+4K180867AmCAD-UOAmcad Biomed Corporation20180—
+4K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+4K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+4K160371NovaPACSNovarad Corporation20165—
+4K151988Visible Patient SuiteVisible Patient, Sas20154—
+4K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+5K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+5K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+5K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+5K244012Mosaic (V1.0.1)Navier Medical20250—
+5K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+5K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+5K230249IkshanaImmersivetouch20231—
+5K221870CarnaLife HoloMedapp S.A.20230—
+5K213215VSI HoloMedicineApoqlar GmbH20222—
+5K212896Visible Patient SuiteVisible Patient, Sas20213—
+5K202084DeepLook PRECISEDeeplook, Inc.20210—
+5K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+5K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+5K171754NovaPACSNovarad Corporation201741
+6K261210Cleerly PlaqueCleerly, Inc.20260—
+6K260588Cleerly LABSCleerly, Inc.20260—
+6K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+6K251577Laia XRAugmented Reality Software S.L.20260—
+6K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+6K240094LumiNE US; LumiAugmedit B.V.20240—
+6K233457RUSHutom, Inc.20240—
+6K231662Aid-UIaid20241—
+6K221796Cyware 4H and Cysart 4HAbys Medical20221—
+6K220039AutoSegAi Medic, Inc.20221—
+6K220727inHEART MODELSInheart, Sas20221—
+6K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+7K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—