510(k) Report

Devices descending from K990426

166 later devices reach Calcium Scoring through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192763syngo.CT CaScoringSiemens Medical Solutions USA, Inc.20193—
+1K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+1K080575CORRIDOR4DMInvia200815—
+1K072737CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C200745—
+1K043111Plaqueview Software, Model CSPV-0001AToshiba America Medical Systems, In.C2004112—
+2K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+2K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+2K201034Syngo.CT CaScoringSiemens Medical Solutions USA, Inc.20202—
+2K172983HealthCCSZebra Medical Vision, Ltd.201814—
+2K101279CORRIDOR4DM V2010 Model: V2010Invia201012—
+2K101013Modification to Scintron IVMiegmbh20101—
+2K083446Cardiac Function Analysis, Calcium ScoringZiosoft, Inc.200929—
+2K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+2K071331Vitrea Version 4.0Vital Images, Inc.2007821
+2K061624Vitrea, Version 3.9Vital Images, Inc.20061111
+3K2608794DMInvia, LLC20260—
+3K241440HealthCCSngNano-X AI, Ltd.20240—
+3K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+3K230112CAC SoftwareImbio, Inc.20230—
+3K230223iCAC DeviceBunkerhill, Inc.20236—
+3K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+3K221219syngo.CT CaScoringSiemens Medical Solutions USA, Inc.20220—
+3K173512MFI-CardiacMultifunctional Imaging, LLC20180—
+3K163071vascuCAPElucid Bioimaging, Inc.20173—
+3K151212Ziostation2Qi Imaging, LLC20152—
+3K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+3K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—
+3K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+3K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+3K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+3K121213VitreaadvancedVital Images, Inc.201281
+3K113754CFR QuantUniversity of Texas Medical School AT Houston20129—
+3K113620Myrian 1.11Intrasense20126—
+3K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+3K121023Spectrum V.0Intrinsic Medical Imaging20120—
+3K120207VISIAMeVis Medical Solutions AG20120—
+3K120484Visia OncologyMeVis Medical Solutions AG20128—
+3K111373CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc.201125—
+3K101768Mie Scintron Gamma Camera SystemsMiegmbh20100—
+3K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+3K091001Myrian 1.4Intrasense20097—
+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—
+3K072821Vitrea 4DCTVital Images, Inc.2008171
+3K072242Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd.20075—
+3K071362Vital Connect 4.1Vital Images, Inc.2007113
+3K071000MyrianIntrasense20078—
+3K063548Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd.20076—
+3K062328Vitreaaccess, Version 1.0Vital Images, Inc.20060—
+4K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+4K260166Bunkerhill Contrast CACBunkerHill Health20260—
+4K250662Bunkerhill MACBunkerHill Health20250—
+4K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+4K243229Bunkerhill AVCBunkerHill Health20253—
+4K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+4K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+4K240786AutoChamberHeartLung Corporation20241—
+4K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+4K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+4K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+4K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+4K213998cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc.20227—
+4K203256Imbio RV/LV SoftwareImbio, LLC202117—
+4K190868Cleerly LabsCleerly, Inc.20197—
+4K183012vascuCAPElucid Bioimaging, Inc.20182—
+4K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+4K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+4K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K153289HealthmyneHealthmyne, Inc.20160—
+4K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+4K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+4K150738VitreaViewVital Images, Inc.20158—
+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—
+4K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+4K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+4K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+4K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+5K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+5K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+5K252029AI-CVDHeartLung Corporation20250—
+5K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+5K243038Salix CentralArtrya Limited20251—
+5K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+5K241922MyomicsPhantomics, Inc.20250—
+5K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+5K2420621CMR ProMycardium AI Limited20240—
+5K241312TeraRecon Cardiac.Chambers.MR (1.0.0)Terarecon,Inc.20240—
+5K241847Imbio PHA (4.0.0)Imbio, Inc.20240—
+5K240620Cube NavigatorMedical Templates AG20240—
+5K223396Rapid RV/LVIschemaview, Inc.20231—
+5K221100Viz RV/LVViz. Ai, Inc.20224—