510(k) Report

Devices descending from K973010

386 later devices reach Realtime 3D Diagnostic Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+1K040126Viatronix V3D Colon, Revision 1.3Viatronix, Inc.20042—
+1K030982Syngo Colonography Software PackageSiemens Medical Solutions USA, Inc.2003227—
+1K023003Imagechecker-CT WorkstationR2 Technology, Inc.2002177—
+1K020658Viatronix V3D ColonViatronix, Inc.20024—
+2K201501VeolityMeVis Medical Solutions AG20210—
+2K123566Synapse 3D Colon AnalysisFujifilm Medical Systems U.S.A, Inc.20130—
+2K111758Cadens (TM) ColonDog Microsystems, Inc.20120—
+2K090220Colon View, Model CSCV-001AToshibamedical Systems Corporation20090—
+2K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+2K050667R2 Family of Image Display Units with R2 Uniform Display SoftwareR2 Technology, Inc.20050—
+2K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc.20041431
+2K042605Colongraphy Software Package with Extended FunctionalitySiemens AG Medical Solutions200476—
+2K041380Imagechecker-CT Software Package with Filling Defect IndicatorR2 Technology, Inc.20043—
+2K040028CA-1500R2 Technology, Inc.20044—
+2K033102Medic Colon Model, Release 1Medicsight2003210—
+2K032748VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc.20031702
+2K031248Consultiva Report Station, Model RS-1Miramedica, Inc.20031—
+2K023943CT ColonographyGe Medical Systems, Inc.20033—
+3K151283Lung Analysis SoftwareVital Images, Inc.20158—
+3K140920Syngo.CT ColonographySiemens Medical Solutions USA, Inc.20140—
+3K141302Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa)Vital Images, Inc.20142—
+3K083423Coloncad Api 3.1Medicsight Plc201170—
+3K091529Icad Veralook CTC Cad SoftwareIcad, Inc.20102—
+3K081556Cadstream, Version 5.0Confirma, Inc.20099—
+3K070868LMS-Lung/TrackMedian Technologies20070—
+3K062164Resolutionmd, Version 1.3Calgary Scientific, Inc.20062—
+3K060378VITREA2 Version 3.8.1Vital Images, Inc.20061—
+3K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc.20051172
+3K042674Colon Car 1.2Medicsight2004209—
+3K042408Iqqa-Chest Software PackageEdda Technology, Inc.20040—
+3K041270CT Colonography IIGeneral Electric Medical Systems20042—
+3K040876Iconnection, Version 3.2.0.0 Medical Image Processing SoftwareVital Images, Inc.200430—
+3K040305VITREA2 Version 3.5Vital Images, Inc.2004164—
+4K241038Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging20241—
+4K222662Vitrea CT Cardiac AnalysisCanon Medical Informatics, Inc.20220—
+4K173744ProFuse CADEigen20181—
+4K170195QuantXQuantitative Insights, Inc.20174—
+4K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V.20177—
+4K160150Vitrea CT Colon AnalysisVital Images, Inc.20160—
+4K151115MR Core SoftwareVital Images, Inc.20153—
+4K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC201369—
+4K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+4K110256The IC-Pro SystemPaieon, Inc.201115—
+4K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc.20101—
+4K092954Cadstream Version 5Confirma, Inc.200983
+4K071086Resolutionmd Cardiac Product Family, Model: Release 1.0Calgary Scientific, Inc.20070—
+4K062328Vitreaaccess, Version 1.0Vital Images, Inc.20060—
+4K062154Vital Connect 4.0Vital Images, Inc.2006124
+4K061624Vitrea, Version 3.9Vital Images, Inc.20061111
+4K061372Centricity AW Suite OptionGe Healthcare Information Technologies200602
+4K061214Aquariusaps ServerTerarecon,Inc.2006134—
+5K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+5K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+5K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+5K240740qCT LN QuantQure.Ai Technologies20240—
+5K231130TumorSight VizSimBioSys, Inc.20232—
+5K221612ClearRead CTRiverain Technologies, Inc.20220—
+5K210670BU-CADTaihao Medical, Inc.20213—
+5K210719Change Healthcare Anatomical AIChange Healthcare Canada Company20210—
+5K202990NinesMeasureNines, Inc.20211—
+5K193220Aview LCSCoreline Soft Co., Ltd.20201—
+5K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+5K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation20183—
+5K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+5K161419Multi Modality ViewerVital Images, Inc.20162—
+5K132853NovapacsNovarad Corp.201462
+5K133993Caas WorkstationPie Medical Imaging201410—
+5K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+5K121916IntuitionTerarecon,Inc.201351
+5K120282CardnavPaieon, Inc.20120—
+5K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp.20120—
+5K113620Myrian 1.11Intrasense20126—
+5K113594C-THV SystemPaieon, Inc.20120—
+5K113076Caas a-ValvePie Medical Imaging BV20121—
+5K112008Touchpacs SuiteTouch Medical Solutions, Inc.20120—
+5K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+5K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc.201014—
+5K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+5K091001Myrian 1.4Intrasense20097—
+5K072242Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd.20075—
+5K071362Vital Connect 4.1Vital Images, Inc.2007113
+5K071331Vitrea Version 4.0Vital Images, Inc.2007821
+5K071000MyrianIntrasense20078—
+5K063548Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd.20076—
+6K260086CadAI-B DxBeamWorks, Inc.20260—
+6K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+6K243189TumorSight VizSimBioSys, Inc.20241—
+6K240786AutoChamberHeartLung Corporation20241—
+6K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+6K203555AmCAD-UTAmcad Biomed Corporation20212—
+6K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+6K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+6K201710A View LCSCoreline Soft Co., Ltd.20200—
+6K200274CariCloudCaristo Diagnostics20200—
+6K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+6K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+6K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+6K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+6K163071vascuCAPElucid Bioimaging, Inc.20173—