510(k) Report

Devices descending from K972903

353 later devices reach Imatron Ultra Access Workstation with Cardiac Software Extensions through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K120484Visia OncologyMeVis Medical Solutions AG20128—
+4K112008Touchpacs SuiteTouch Medical Solutions, Inc.20120—
+4K112480View 1 ImagingKarl Storz Endoscopy America, Inc.20110—
+4K111373CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc.201125—
+4K111319Ibis Explorer and Markup SoftwareMedqia20116—
+4K110844Symbia.NetSiemens Medical Solutions USA, Inc.20110—
+4K101768Mie Scintron Gamma Camera SystemsMiegmbh20100—
+4K093612Syngo.PlazaSiemens AG Medical Solutions20101016
+4K0937033DIShina Systems, Ltd.20102—
+4K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+4K091001Myrian 1.4Intrasense20097—
+4K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+4K083691BonevueMicromri, Inc.20090—
+4K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+4K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+4K072821Vitrea 4DCTVital Images, Inc.2008171
+4K072242Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd.20075—
+4K071362Vital Connect 4.1Vital Images, Inc.2007113
+4K071000MyrianIntrasense20078—
+4K063548Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd.20076—
+4K062328Vitreaaccess, Version 1.0Vital Images, Inc.20060—
+5K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+5K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+5K260166Bunkerhill Contrast CACBunkerHill Health20260—
+5K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+5K250662Bunkerhill MACBunkerHill Health20250—
+5K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+5K243666uOmniscanShanghai United Imaging Healthcare Co., Ltd.20250—
+5K243703TechLiveDeepHealth, Inc.20250—
+5K243333rTOPRoclub GmbH20250—
+5K243229Bunkerhill AVCBunkerHill Health20253—
+5K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+5K242329CT Collaboration LivePhilips Healthcare (Suzhou) Co., Ltd.20240—
+5K241981Change Healthcare Stratus Imaging PACSChange Healthcare Canada Company20240—
+5K242512ROCC ConsolePhilips Medical Systems Nederland B.V.20240—
+5K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+5K240786AutoChamberHeartLung Corporation20241—
+5K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+5K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+5K223261Open RibCanon Medical Informatics, Inc.20230—
+5K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+5K222476OmegaAI Image ViewerRamsoft, Inc.20223—
+5K220929ExcelsiorMerit Cro, Inc.20220—
+5K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+5K220349TeraRecon NeuroTerarecon,Inc.20220—
+5K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+5K213998cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc.20227—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+5K203256Imbio RV/LV SoftwareImbio, LLC202117—
+5K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+5K202229AI MetricsAi Metrics, LLC20200—
+5K201665Collaboration LivePhilips Ultrasound, Inc.20202—
+5K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+5K190868Cleerly LabsCleerly, Inc.20197—
+5K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+5K183012vascuCAPElucid Bioimaging, Inc.20182—
+5K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+5K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+5K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+5K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+5K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+5K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+5K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+5K171754NovaPACSNovarad Corporation201741
+5K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+5K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+5K153289HealthmyneHealthmyne, Inc.20160—
+5K151988Visible Patient SuiteVisible Patient, Sas20154—
+5K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+5K150843syngo®.via (version VB10A)Siemens AG201546—
+5K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+5K150738VitreaViewVital Images, Inc.20158—
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+5K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+5K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+5K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+5K141329RadspaTelerad Tech Private Limited20140—
+5K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+5K122205EXINIExini Diagnostics AB20125—
+5K1125303DI Including CscoreShina Systems, Ltd.20111—
+5K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+5K101666Syngo. Plaza VA20ASiemens AG Medical Solutions201093
+5K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+6K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+6K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl.20260—
+6K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+6K252029AI-CVDHeartLung Corporation20250—
+6K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K243038Salix CentralArtrya Limited20251—
+6K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+6K241922MyomicsPhantomics, Inc.20250—
+6K241546aiCockpit AI ViewerFovia, Inc.20250—
+6K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+6K242362Lightning ViewerNexsys Electronics Inc. Dba Medweb20240—
+6K2420621CMR ProMycardium AI Limited20240—