510(k) Report

Devices descending from K041267

331 later devices reach Cardiq Analysis Iii through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083293Viatronix V3D-Cardiac, Revision 1.0Viatronix, Inc.20080—
+1K073153Cardiq Function XpressGE Medical Systems SCS200829—
+1K073138Cardiq Express Version 2.0GE Medical Systems200832—
+1K061372Centricity AW Suite OptionGe Healthcare Information Technologies200602
+1K061370Cardiq FusionGE Healthcare200651—
+1K060779Advance Vessel Analysis IIGE Healthcare200655—
+1K052029Syngo CirculationSiemens AG Medical Solutions2005296—
+2K200626VesselIQ XpressGE Medical Systems SCS20210—
+2K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+2K151212Ziostation2Qi Imaging, LLC20152—
+2K141302Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa)Vital Images, Inc.20142—
+2K132523MyoperfusionToshibamedical Systems Corporation201311
+2K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+2K120910Cardiq Xpress 2.0 with Snapshot Freeze Option Cardiq Xpress 2.0 RevealGE Medical Systems SCS20122—
+2K113543ONDEMAND3DCybermed, Inc.20119—
+2K112531Vitrea CT Myocardial AnalysisVital Images, Inc.20116—
+2K110366Syngo.CT Cardiac FunctionSiemens AG2011251
+2K103465Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc.201120—
+2K100637Syngo.CT Coronary AnalysisSiemens AG Medical Solutions20102—
+2K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+2K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+2K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc.2008168—
+2K063762Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions2007263—
+3K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+3K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+3K240786AutoChamberHeartLung Corporation20241—
+3K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+3K241038Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging20241—
+3K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+3K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+3K201250SQuEEZ SoftwareCardiowise, Inc.20200—
+3K190868Cleerly LabsCleerly, Inc.20197—
+3K183161SnapShot Freeze 2Ge Medical Systems, LLC20190—
+3K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+3K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+3K181892Ziostation2Ziosoft, Inc.20181—
+3K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+3K152746Ez3D PlusEwoosoft Co., Ltd.20161—
+3K143294Adaptive Motion Correction (AMC), CSMC-001A and 4D AirwaysToshibamedical Systems Corporation20150—
+3K150104Vitrea CT Myocardial PerfusionVital Images, Inc.20150—
+3K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+3K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+3K132773Sidexis 4Sirona Dental Systems GmbH20131—
+3K131616EZ3D-I, E3Ewoosoft Co., Ltd.20134—
+3K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+3K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+3K101279CORRIDOR4DM V2010 Model: V2010Invia201012—
+3K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+3K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+3K083327Syngocirculation Dynamicpet, Version 1.0Siemens Medical Solutions USA, Inc.200920—
+3K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+4K2608794DMInvia, LLC20260—
+4K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+4K252029AI-CVDHeartLung Corporation20250—
+4K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+4K250755DS Core DiagnosisDentsply Sirona, Inc.20250—
+4K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+4K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+4K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+4K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+4K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+4K200315Ziostation2Ziosoft, Inc.20200—
+4K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+4K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+4K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+4K173512MFI-CardiacMultifunctional Imaging, LLC20180—
+4K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+4K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+4K160666Dentiq3D3D Industrial Imaging Co., Ltd.20160—
+4K161201ClearRead CTRiverain Technologies, LLC20165—
+4K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+4K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+4K150761Ez3D-i/E3Ewoosoft Co., Ltd.20153—
+4K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+4K133648Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc.201416—
+4K133521Aze Phoenix SoftwareAze, Ltd.20140—
+4K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+4K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+4K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+4K130393Mirada RTXMirada Medical, Ltd.201336—
+4K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+4K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+4K113754CFR QuantUniversity of Texas Medical School AT Houston20129—
+4K113620Myrian 1.11Intrasense20126—
+4K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+4K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+4K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+4K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+4K110494Syngo MBFSiemens Medical Solutions USA, Inc.20116—
+4K102687Mirada RTMirada Medical, Ltd.201037—
+4K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+4K101228Mirada XDMirada Medical, Ltd.201070—
+5K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+5K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+5K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+5K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+5K242919V5med Lung AIV5med, Inc.20250—
+5K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+5K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+5K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—