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
+1K060035MdxnetCybermdx, Inc.20060—
+1K040782N-Vivo Calcium Score on IA Chassis Release, Model Release X.XXImage Analysis, Inc.20040—
+1K012086Aquariusnet ServerTerarecon,Inc.2001207—
+1K990241Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze, Accuscope…Accuimage Diagnostics Corp.19998—
+1K990426Calcium ScoringSiemens Medical Solutions USA, Inc.1999166—
+2K192763syngo.CT CaScoringSiemens Medical Solutions USA, Inc.20193—
+2K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+2K121916IntuitionTerarecon,Inc.201351
+2K081985AW ServerGe Medical Systems, LLC2008275
+2K080575CORRIDOR4DMInvia200815—
+2K072737CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C200745—
+2K072205Visage Pacs/CS, Release Version 5.0Mercury Computer Systems, Inc.200736—
+2K063221Medweb Advanced 3D Web PacsNexsys Electronics, Inc.20061—
+2K062490Visage Pacs/CS, Release Version 4.1Mercury Computer Systems, Inc.20067—
+2K061214Aquariusaps ServerTerarecon,Inc.2006134—
+2K060840SVIEWMri Cardiac Services, Incorporated20060—
+2K051809Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data Management SystemMedical Insight A/S20052—
+2K043111Plaqueview Software, Model CSPV-0001AToshiba America Medical Systems, In.C2004112—
+2K032546Hologic DR ImageproHologic, Inc.20030—
+2K024149PrimelungAccuimage Diagnostics Corp.20031—
+2K021913Calscor Software3D Med Co., Ltd.20020—
+3K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+3K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+3K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+3K210719Change Healthcare Anatomical AIChange Healthcare Canada Company20210—
+3K200274CariCloudCaristo Diagnostics20200—
+3K201034Syngo.CT CaScoringSiemens Medical Solutions USA, Inc.20202—
+3K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+3K172983HealthCCSZebra Medical Vision, Ltd.201814—
+3K162025IntelliSpace Portal PlatformPhilips Medical Systems Nederlands B.V.20161—
+3K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+3K150193Customer Remote Console (CRC)Ge Medical Systems, LLC201512—
+3K132853NovapacsNovarad Corp.201462
+3K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+3K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp.20120—
+3K113620Myrian 1.11Intrasense20126—
+3K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+3K111642Onco Trac Model 1, 2, 4Translational Sciences Corporation20113—
+3K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+3K101279CORRIDOR4DM V2010 Model: V2010Invia201012—
+3K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc.201014—
+3K101013Modification to Scintron IVMiegmbh20101—
+3K100619Symbia.Net, Symbia.Net Select Model 10520828, 10520827Siemens Medical Solutions USA, Inc.20101—
+3K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc.20101—
+3K092134Stat Pacs Picture Archiving & Communication System (Pacs)Statrad, LLC20091—
+3K083446Cardiac Function Analysis, Calcium ScoringZiosoft, Inc.200929—
+3K082269Visage Pacs, Version 6.0/CS 3.1Visage Imaging, Inc.200820—
+3K082430Syngo Imaging XSSiemens AG Medical Solutions20081112
+3K082336XR-ExpressNew Mexico Software, Inc.20080—
+3K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+3K080334InstaradMedsphere Technologies Pvt, Ltd.20082—
+3K073306XoranconnectXoran Technologies, Inc.200801
+3K071331Vitrea Version 4.0Vital Images, Inc.2007821
+3K070868LMS-Lung/TrackMedian Technologies20070—
+3K063392Imco-StatImco Technologies20061—
+3K061624Vitrea, Version 3.9Vital Images, Inc.20061111
+4K2608794DMInvia, LLC20260—
+4K253927LiveMedica Enterprise PACSLive Medica, LLC20260—
+4K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+4K241440HealthCCSngNano-X AI, Ltd.20240—
+4K233660nCommand Lite SystemIonic Health20240—
+4K232744syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH20234—
+4K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+4K232346Digital Expert Access with Remote ScanningGE Healthcare20230—
+4K230112CAC SoftwareImbio, Inc.20230—
+4K230223iCAC DeviceBunkerhill, Inc.20236—
+4K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+4K221219syngo.CT CaScoringSiemens Medical Solutions USA, Inc.20220—
+4K203249Nucleus.ioNucleushealth, LLC202051
+4K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+4K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+4K200899Quantib AI NodeQuantib B.V.20200—
+4K200179Collaboration LivePhilips Health Care20204—
+4K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+4K173512MFI-CardiacMultifunctional Imaging, LLC20180—
+4K163071vascuCAPElucid Bioimaging, Inc.20173—
+4K171130Nucleus Image Management SystemNucleushealth, LLC20170—
+4K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+4K160371NovaPACSNovarad Corporation20165—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K151212Ziostation2Qi Imaging, LLC20152—
+4K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+4K142196Visage Ease ProVisage Imaging GmbH20150—
+4K142647mint LesionMint Medical GmbH201523
+4K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—
+4K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+4K133357Charruapacs SystemCharruasoft SA20130—
+4K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+4K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+4K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+4K123920Syngo.ViaSiemens AG Medical Solutions201363—
+4K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+4K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+4K121213VitreaadvancedVital Images, Inc.201281
+4K113754CFR QuantUniversity of Texas Medical School AT Houston20129—
+4K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+4K121023Spectrum V.0Intrinsic Medical Imaging20120—
+4K120207VISIAMeVis Medical Solutions AG20120—
+4K120718Instapacs/InstarispacsMeddiff Technologies Pvt., Ltd.20120—
+4K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—