510(k) Report

Devices descending from K000315

450 later devices reach Ventricular Analysis Toolkit Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013422Cardiq FunctionGE Medical Systems2001449—
+2K083293Viatronix V3D-Cardiac, Revision 1.0Viatronix, Inc.20080—
+2K073153Cardiq Function XpressGE Medical Systems SCS200829—
+2K061370Cardiq FusionGE Healthcare200651—
+2K041267Cardiq Analysis IiiGeneral Electric Medical Systems2004331—
+2K033774CT-MassMedis Medical Imaging Systems BV20040—
+2K023760CT Cardiac Function Analysis Software, Models CSCF-001A and CSCF-001BToshiba America Medical Systems, In.C2002174—
+3K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+3K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+3K141302Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa)Vital Images, Inc.20142—
+3K113543ONDEMAND3DCybermed, Inc.20119—
+3K110366Syngo.CT Cardiac FunctionSiemens AG2011251
+3K103465Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc.201120—
+3K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+3K083446Cardiac Function Analysis, Calcium ScoringZiosoft, Inc.200929—
+3K073138Cardiq Express Version 2.0GE Medical Systems200832—
+3K061372Centricity AW Suite OptionGe Healthcare Information Technologies200602
+3K060779Advance Vessel Analysis IIGE Healthcare200655—
+3K052029Syngo CirculationSiemens AG Medical Solutions2005296—
+3K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc.20041431
+4K240786AutoChamberHeartLung Corporation20241—
+4K241038Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging20241—
+4K200626VesselIQ XpressGE Medical Systems SCS20210—
+4K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+4K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+4K152746Ez3D PlusEwoosoft Co., Ltd.20161—
+4K151212Ziostation2Qi Imaging, LLC20152—
+4K151283Lung Analysis SoftwareVital Images, Inc.20158—
+4K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+4K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+4K132523MyoperfusionToshibamedical Systems Corporation201311
+4K132773Sidexis 4Sirona Dental Systems GmbH20131—
+4K131616EZ3D-I, E3Ewoosoft Co., Ltd.20134—
+4K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+4K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+4K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+4K120910Cardiq Xpress 2.0 with Snapshot Freeze Option Cardiq Xpress 2.0 RevealGE Medical Systems SCS20122—
+4K111758Cadens (TM) ColonDog Microsystems, Inc.20120—
+4K112531Vitrea CT Myocardial AnalysisVital Images, Inc.20116—
+4K111373CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc.201125—
+4K100637Syngo.CT Coronary AnalysisSiemens AG Medical Solutions20102—
+4K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+4K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc.2008168—
+4K063762Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions2007263—
+4K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc.20051172
+4K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+5K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+5K252029AI-CVDHeartLung Corporation20250—
+5K250755DS Core DiagnosisDentsply Sirona, Inc.20250—
+5K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+5K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+5K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+5K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+5K222662Vitrea CT Cardiac AnalysisCanon Medical Informatics, Inc.20220—
+5K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+5K213998cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc.20227—
+5K203256Imbio RV/LV SoftwareImbio, LLC202117—
+5K201250SQuEEZ SoftwareCardiowise, Inc.20200—
+5K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+5K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+5K190868Cleerly LabsCleerly, Inc.20197—
+5K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+5K183161SnapShot Freeze 2Ge Medical Systems, LLC20190—
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+5K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+5K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+5K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V.20177—
+5K160666Dentiq3D3D Industrial Imaging Co., Ltd.20160—
+5K160150Vitrea CT Colon AnalysisVital Images, Inc.20160—
+5K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+5K150761Ez3D-i/E3Ewoosoft Co., Ltd.20153—
+5K143294Adaptive Motion Correction (AMC), CSMC-001A and 4D AirwaysToshibamedical Systems Corporation20150—
+5K150104Vitrea CT Myocardial PerfusionVital Images, Inc.20150—
+5K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+5K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+5K101279CORRIDOR4DM V2010 Model: V2010Invia201012—
+5K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+5K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+5K083327Syngocirculation Dynamicpet, Version 1.0Siemens Medical Solutions USA, Inc.200920—
+5K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+5K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+5K071086Resolutionmd Cardiac Product Family, Model: Release 1.0Calgary Scientific, Inc.20070—
+5K061624Vitrea, Version 3.9Vital Images, Inc.20061111
+5K060378VITREA2 Version 3.8.1Vital Images, Inc.20061—
+6K2608794DMInvia, LLC20260—
+6K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+6K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+6K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+6K243038Salix CentralArtrya Limited20251—
+6K241922MyomicsPhantomics, Inc.20250—
+6K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+6K2420621CMR ProMycardium AI Limited20240—
+6K241312TeraRecon Cardiac.Chambers.MR (1.0.0)Terarecon,Inc.20240—
+6K241847Imbio PHA (4.0.0)Imbio, Inc.20240—
+6K240740qCT LN QuantQure.Ai Technologies20240—
+6K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+6K223396Rapid RV/LVIschemaview, Inc.20231—
+6K221612ClearRead CTRiverain Technologies, Inc.20220—
+6K221100Viz RV/LVViz. Ai, Inc.20224—