510(k) Report

Devices descending from K020796

377 later devices reach Card IQ Analysis II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063184Model CVV-001A Vessel View Software OptionToshiba America Medical Systems, In.C20060—
+1K041267Cardiq Analysis IiiGeneral Electric Medical Systems2004331—
+1K033774CT-MassMedis Medical Imaging Systems BV20040—
+1K031261Card EPGE Medical Systems200384—
+2K151212Ziostation2Qi Imaging, LLC20152—
+2K083293Viatronix V3D-Cardiac, Revision 1.0Viatronix, Inc.20080—
+2K073153Cardiq Function XpressGE Medical Systems SCS200829—
+2K073138Cardiq Express Version 2.0GE Medical Systems200832—
+2K071331Vitrea Version 4.0Vital Images, Inc.2007821
+2K061372Centricity AW Suite OptionGe Healthcare Information Technologies200602
+2K061370Cardiq FusionGE Healthcare200651—
+2K060779Advance Vessel Analysis IIGE Healthcare200655—
+2K052029Syngo CirculationSiemens AG Medical Solutions2005296—
+3K200626VesselIQ XpressGE Medical Systems SCS20210—
+3K181892Ziostation2Ziosoft, Inc.20181—
+3K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+3K163071vascuCAPElucid Bioimaging, Inc.20173—
+3K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+3K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—
+3K141302Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa)Vital Images, Inc.20142—
+3K132523MyoperfusionToshibamedical Systems Corporation201311
+3K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+3K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+3K121213VitreaadvancedVital Images, Inc.201281
+3K120910Cardiq Xpress 2.0 with Snapshot Freeze Option Cardiq Xpress 2.0 RevealGE Medical Systems SCS20122—
+3K121023Spectrum V.0Intrinsic Medical Imaging20120—
+3K120207VISIAMeVis Medical Solutions AG20120—
+3K120484Visia OncologyMeVis Medical Solutions AG20128—
+3K113543ONDEMAND3DCybermed, Inc.20119—
+3K112531Vitrea CT Myocardial AnalysisVital Images, Inc.20116—
+3K110366Syngo.CT Cardiac FunctionSiemens AG2011251
+3K103465Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc.201120—
+3K100637Syngo.CT Coronary AnalysisSiemens AG Medical Solutions20102—
+3K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+3K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+3K083691BonevueMicromri, Inc.20090—
+3K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+3K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+3K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+3K072821Vitrea 4DCTVital Images, Inc.2008171
+3K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc.2008168—
+3K063762Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions2007263—
+4K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+4K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+4K240786AutoChamberHeartLung Corporation20241—
+4K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+4K241038Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging20241—
+4K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+4K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+4K201250SQuEEZ SoftwareCardiowise, Inc.20200—
+4K200315Ziostation2Ziosoft, Inc.20200—
+4K190868Cleerly LabsCleerly, Inc.20197—
+4K183161SnapShot Freeze 2Ge Medical Systems, LLC20190—
+4K183012vascuCAPElucid Bioimaging, Inc.20182—
+4K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+4K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+4K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+4K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+4K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+4K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+4K153289HealthmyneHealthmyne, Inc.20160—
+4K152746Ez3D PlusEwoosoft Co., Ltd.20161—
+4K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+4K143294Adaptive Motion Correction (AMC), CSMC-001A and 4D AirwaysToshibamedical Systems Corporation20150—
+4K150104Vitrea CT Myocardial PerfusionVital Images, Inc.20150—
+4K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+4K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+4K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+4K132853NovapacsNovarad Corp.201462
+4K141329RadspaTelerad Tech Private Limited20140—
+4K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+4K132773Sidexis 4Sirona Dental Systems GmbH20131—
+4K131616EZ3D-I, E3Ewoosoft Co., Ltd.20134—
+4K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+4K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+4K101279CORRIDOR4DM V2010 Model: V2010Invia201012—
+4K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+4K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+4K083327Syngocirculation Dynamicpet, Version 1.0Siemens Medical Solutions USA, Inc.200920—
+4K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+4K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+5K2608794DMInvia, LLC20260—
+5K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+5K252029AI-CVDHeartLung Corporation20250—
+5K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+5K250755DS Core DiagnosisDentsply Sirona, Inc.20250—
+5K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+5K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+5K240620Cube NavigatorMedical Templates AG20240—
+5K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+5K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+5K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+5K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+5K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+5K191530StoneCheckerImaging Biometrics, LLC20191—
+5K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+5K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+5K180867AmCAD-UOAmcad Biomed Corporation20180—
+5K173512MFI-CardiacMultifunctional Imaging, LLC20180—
+5K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—