510(k) Report

Devices descending from K043333

143 later devices reach VITREA2, Version 3.7 Medical Image Processing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151283Lung Analysis SoftwareVital Images, Inc.20158—
+1K141302Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa)Vital Images, Inc.20142—
+1K111758Cadens (TM) ColonDog Microsystems, Inc.20120—
+1K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc.20051172
+1K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+2K241038Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging20241—
+2K222662Vitrea CT Cardiac AnalysisCanon Medical Informatics, Inc.20220—
+2K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V.20177—
+2K160150Vitrea CT Colon AnalysisVital Images, Inc.20160—
+2K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+2K071086Resolutionmd Cardiac Product Family, Model: Release 1.0Calgary Scientific, Inc.20070—
+2K061624Vitrea, Version 3.9Vital Images, Inc.20061111
+2K060378VITREA2 Version 3.8.1Vital Images, Inc.20061—
+3K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+3K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+3K240740qCT LN QuantQure.Ai Technologies20240—
+3K221612ClearRead CTRiverain Technologies, Inc.20220—
+3K202990NinesMeasureNines, Inc.20211—
+3K201501VeolityMeVis Medical Solutions AG20210—
+3K193220Aview LCSCoreline Soft Co., Ltd.20201—
+3K113620Myrian 1.11Intrasense20126—
+3K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+3K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+3K091001Myrian 1.4Intrasense20097—
+3K081556Cadstream, Version 5.0Confirma, Inc.20099—
+3K072242Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd.20075—
+3K071362Vital Connect 4.1Vital Images, Inc.2007113
+3K071331Vitrea Version 4.0Vital Images, Inc.2007821
+3K071000MyrianIntrasense20078—
+3K063548Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd.20076—
+3K062328Vitreaaccess, Version 1.0Vital Images, Inc.20060—
+4K240786AutoChamberHeartLung Corporation20241—
+4K201710A View LCSCoreline Soft Co., Ltd.20200—
+4K163071vascuCAPElucid Bioimaging, Inc.20173—
+4K170195QuantXQuantitative Insights, Inc.20174—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+4K150738VitreaViewVital Images, Inc.20158—
+4K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—
+4K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+4K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+4K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+4K121213VitreaadvancedVital Images, Inc.201281
+4K121023Spectrum V.0Intrinsic Medical Imaging20120—
+4K120207VISIAMeVis Medical Solutions AG20120—
+4K120484Visia OncologyMeVis Medical Solutions AG20128—
+4K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+4K092954Cadstream Version 5Confirma, Inc.200983
+4K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+4K083691BonevueMicromri, Inc.20090—
+4K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+4K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+4K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+4K072821Vitrea 4DCTVital Images, Inc.2008171
+5K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+5K252029AI-CVDHeartLung Corporation20250—
+5K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+5K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+5K231130TumorSight VizSimBioSys, Inc.20232—
+5K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+5K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+5K210670BU-CADTaihao Medical, Inc.20213—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K190868Cleerly LabsCleerly, Inc.20197—
+5K183012vascuCAPElucid Bioimaging, Inc.20182—
+5K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+5K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+5K163232Vitrea ViewVital Images, Inc.20177—
+5K153289HealthmyneHealthmyne, Inc.20160—
+5K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+5K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+5K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+5K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+5K132853NovapacsNovarad Corp.201462
+5K141329RadspaTelerad Tech Private Limited20140—
+5K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+5K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+5K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+6K260086CadAI-B DxBeamWorks, Inc.20260—
+6K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+6K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+6K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+6K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+6K243189TumorSight VizSimBioSys, Inc.20241—
+6K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+6K240620Cube NavigatorMedical Templates AG20240—
+6K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+6K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+6K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+6K200315Ziostation2Ziosoft, Inc.20200—
+6K191530StoneCheckerImaging Biometrics, LLC20191—
+6K190764SurgicalARMedivis, Inc.20196—
+6K180867AmCAD-UOAmcad Biomed Corporation20180—
+6K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+6K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+6K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—