510(k) Report

Devices descending from K023760

174 later devices reach CT Cardiac Function Analysis Software, Models CSCF-001A and CSCF-001B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+1K083446Cardiac Function Analysis, Calcium ScoringZiosoft, Inc.200929—
+1K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc.20041431
+2K151212Ziostation2Qi Imaging, LLC20152—
+2K151283Lung Analysis SoftwareVital Images, Inc.20158—
+2K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+2K141302Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa)Vital Images, Inc.20142—
+2K111758Cadens (TM) ColonDog Microsystems, Inc.20120—
+2K111373CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc.201125—
+2K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc.20051172
+2K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+3K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+3K241038Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging20241—
+3K222662Vitrea CT Cardiac AnalysisCanon Medical Informatics, Inc.20220—
+3K213998cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc.20227—
+3K203256Imbio RV/LV SoftwareImbio, LLC202117—
+3K181892Ziostation2Ziosoft, Inc.20181—
+3K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V.20177—
+3K160150Vitrea CT Colon AnalysisVital Images, Inc.20160—
+3K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+3K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+3K071086Resolutionmd Cardiac Product Family, Model: Release 1.0Calgary Scientific, Inc.20070—
+3K061624Vitrea, Version 3.9Vital Images, Inc.20061111
+3K060378VITREA2 Version 3.8.1Vital Images, Inc.20061—
+4K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+4K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+4K243038Salix CentralArtrya Limited20251—
+4K241922MyomicsPhantomics, Inc.20250—
+4K2420621CMR ProMycardium AI Limited20240—
+4K241312TeraRecon Cardiac.Chambers.MR (1.0.0)Terarecon,Inc.20240—
+4K240786AutoChamberHeartLung Corporation20241—
+4K241847Imbio PHA (4.0.0)Imbio, Inc.20240—
+4K240740qCT LN QuantQure.Ai Technologies20240—
+4K223396Rapid RV/LVIschemaview, Inc.20231—
+4K221612ClearRead CTRiverain Technologies, Inc.20220—
+4K221100Viz RV/LVViz. Ai, Inc.20224—
+4K220624AI4CMR v1.0Ai4medimaging Medical Solutions S.A.20222—
+4K212624EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune.Ai, Co., Ltd.20223—
+4K202990NinesMeasureNines, Inc.20211—
+4K201501VeolityMeVis Medical Solutions AG20210—
+4K193220Aview LCSCoreline Soft Co., Ltd.20201—
+4K200315Ziostation2Ziosoft, Inc.20200—
+4K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+4K113620Myrian 1.11Intrasense20126—
+4K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+4K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+4K091001Myrian 1.4Intrasense20097—
+4K081556Cadstream, Version 5.0Confirma, Inc.20099—
+4K072242Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd.20075—
+4K071362Vital Connect 4.1Vital Images, Inc.2007113
+4K071331Vitrea Version 4.0Vital Images, Inc.2007821
+4K071000MyrianIntrasense20078—
+4K063548Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd.20076—
+4K062328Vitreaaccess, Version 1.0Vital Images, Inc.20060—
+5K252084AI4CMR v2.0Ai4medimaging Medical Solutions S.A.20260—
+5K252029AI-CVDHeartLung Corporation20250—
+5K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+5K243378Rapid MLSIschemaview, Inc.20250—
+5K232613CT CardiomegalyInnolitics, LLC20241—
+5K230534BriefCase-QuantificationAidoc Medical, Ltd.20233—
+5K231149qXR-CTRQure.Ai Technologies20230—
+5K201710A View LCSCoreline Soft Co., Ltd.20200—
+5K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+5K163071vascuCAPElucid Bioimaging, Inc.20173—
+5K170195QuantXQuantitative Insights, Inc.20174—
+5K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+5K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+5K150738VitreaViewVital Images, Inc.20158—
+5K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—
+5K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+5K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+5K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+5K121213VitreaadvancedVital Images, Inc.201281
+5K121023Spectrum V.0Intrinsic Medical Imaging20120—
+5K120207VISIAMeVis Medical Solutions AG20120—
+5K120484Visia OncologyMeVis Medical Solutions AG20128—
+5K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+5K092954Cadstream Version 5Confirma, Inc.200983
+5K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+5K083691BonevueMicromri, Inc.20090—
+5K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+5K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+5K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+5K072821Vitrea 4DCTVital Images, Inc.2008171
+6K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+6K243859PRAEVAorta®2Nurea20250—
+6K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+6K243779Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health20250—
+6K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+6K241112BriefCase-QuantificationAidoc Medical, Ltd.20241—
+6K231130TumorSight VizSimBioSys, Inc.20232—
+6K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+6K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+6K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+6K210670BU-CADTaihao Medical, Inc.20213—
+6K211655aPROMISEExini Diagnostics AB20211—
+6K190868Cleerly LabsCleerly, Inc.20197—
+6K183012vascuCAPElucid Bioimaging, Inc.20182—
+6K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+6K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—