510(k) Report

Devices descending from K020483

872 later devices reach Advantage Workstation 4.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183193MREplus+ SoftwareResoundant, Inc.20190—
+1K052995Advantage Workstation 4.3.GE Healthcare20051134
+1K033400Seno AdvantageGe Medical Systems W-40020036376
+1K032748VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc.20031702
+1K023003Imagechecker-CT WorkstationR2 Technology, Inc.2002177—
+2K201501VeolityMeVis Medical Solutions AG20210—
+2K110834AW Volumeshare 5 with Angioviz OptionGE Healthcare2011131
+2K092639Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision…GE Medical Systems SCS200965—
+2K091001Myrian 1.4Intrasense20097—
+2K090552UrocareNeusoft Medical Systems Co., Ltd.20090—
+2K083740Mammodiagnost VUPhilips Medical Systems Nederland B.V.20090—
+2K081985AW ServerGe Medical Systems, LLC2008275
+2K080351Dexela Dex Top Mammography Workstation, Model MamwkviDexela, Ltd.20082—
+2K073272Workstationone Breast Imaging WorkstationThree Palm Software, LLC200727—
+2K071000MyrianIntrasense20078—
+2K062164Resolutionmd, Version 1.3Calgary Scientific, Inc.20062—
+2K061587Fullcard AnalysisGE Healthcare20061—
+2K060453Aze VirtualplaceAze, Ltd.20061—
+2K052537Catella Diagnostic Workstation, Version 4.0American Medical Sales, Inc.20050—
+2K050667R2 Family of Image Display Units with R2 Uniform Display SoftwareR2 Technology, Inc.20050—
+2K043415Centricity Pacs SystemGe Medical Systems Information Technologies200532423
+2K043216Cadstream Version 4.0Confirma, Inc.2005263—
+2K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc.20041431
+2K041935DR Systems Pacs, Release 6.1Dr Systems, Inc.200416
+2K041555Securview DX Softcopy WorkstationHologic, Inc.200416—
+2K041380Imagechecker-CT Software Package with Filling Defect IndicatorR2 Technology, Inc.20043—
+2K040555Impax Client EmbraceAgfa Corp.200463
+2K040876Iconnection, Version 3.2.0.0 Medical Image Processing SoftwareVital Images, Inc.200430—
+2K040305VITREA2 Version 3.5Vital Images, Inc.2004164—
+2K040028CA-1500R2 Technology, Inc.20044—
+2K031248Consultiva Report Station, Model RS-1Miramedica, Inc.20031—
+3K223152Vision 2, EVARVision, TrackVision 2, HeartVision 2GE Medical Systems SCS20220—
+3K210830VUZE SystemVuze Medical, Ltd.20221—
+3K211039BIT-MotionDde Mri Solutions, Ltd.20210—
+3K192277CardIQ FlowGE Medical Systems SCS20200—
+3K162025IntelliSpace Portal PlatformPhilips Medical Systems Nederlands B.V.20161—
+3K152352Stereo 3D option for Vision ApplicationsGE Medical Systems SCS20161—
+3K151212Ziostation2Qi Imaging, LLC20152—
+3K151283Lung Analysis SoftwareVital Images, Inc.20158—
+3K151115MR Core SoftwareVital Images, Inc.20153—
+3K150193Customer Remote Console (CRC)Ge Medical Systems, LLC201512—
+3K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+3K141364Climb Mammography Viewer SoftwareClimb Medical Systems, Inc.20140—
+3K141302Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa)Vital Images, Inc.20142—
+3K133521Aze Phoenix SoftwareAze, Ltd.20140—
+3K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+3K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+3K130069Innova Epvision 2.0, Innova Epvision 2.0GE Healthcare20130—
+3K121772Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1Philips Medical Systems Nederland B.V.201315—
+3K113620Myrian 1.11Intrasense20126—
+3K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+3K111758Cadens (TM) ColonDog Microsystems, Inc.20120—
+3K111642Onco Trac Model 1, 2, 4Translational Sciences Corporation20113—
+3K112096ImagelinkComputer Programs and Systems, Inc.20110—
+3K110256The IC-Pro SystemPaieon, Inc.201115—
+3K110875Centricity PacsGE Healthcare2011610
+3K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+3K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc.20101—
+3K091368R2 Digitalnow HD (Digitalnow HD)Hologic, Inc.20091—
+3K090038Syngo BrevisSiemens Medical Solutions USA, Inc.20090—
+3K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.200901
+3K081168Brit Pacs SystemsBrit Systems, Inc.20090—
+3K081556Cadstream, Version 5.0Confirma, Inc.20099—
+3K083018Centricity Pacs Web DiagnosticGe Healthcare Dynamic Imaging Solutions200894
+3K081948Raypax SystemRaypax, Inc.20080—
+3K082483QuantraHologic, Inc.200825—
+3K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+3K081976Impax MA3000 Diagnostic Pacs WorkstationAgfa Healthcare Corporation200841
+3K071964Mim 4.1 (Seastar)Mimvista Corp.20072872
+3K071492FirstviewRiverain Medical Group,Llc20070—
+3K071297Impax SE Sigmacom Client (Pacs Workstation)Agfa Healthcare Corp.200701
+3K070868LMS-Lung/TrackMedian Technologies20070—
+3K070244AEGISSentinelle Medical, Inc.200789—
+3K063267Isite Pacs, V 4. XStentor Inc., A Philips Medical Systems Co.200684
+3K062757Xeron PacsXeron Healthcare Corp.20060—
+3K062059Aie Region of Interest Image EnhancementAdvanced Image Enhancement20060—
+3K062328Vitreaaccess, Version 1.0Vital Images, Inc.20060—
+3K062107Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and SV-0003Hologic, Inc.200614—
+3K062154Vital Connect 4.0Vital Images, Inc.2006124
+3K061372Centricity AW Suite OptionGe Healthcare Information Technologies200602
+3K060378VITREA2 Version 3.8.1Vital Images, Inc.20061—
+3K053458WEB1000Agfa Corp.200552
+3K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc.20051172
+3K052023Cadimas Version 1.0Alan Penn & Associates., Inc.20050—
+3K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+3K052460Powerserver, Powerreader, Gateway and PowercacheRamsoft, Inc.20050—
+3K052305Mri Soft Tissue Motion Correction Software VA10ASiemens Medical Solutions USA, Inc.200534—
+3K050846B-Cad System, Version 1.0The Medipattern Corporation2005123—
+3K042408Iqqa-Chest Software PackageEdda Technology, Inc.20040—
+4K241038Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging20241—
+4K232976VUZE SystemVuze Medical, Ltd.20240—
+4K233660nCommand Lite SystemIonic Health20240—
+4K232744syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH20234—
+4K232346Digital Expert Access with Remote ScanningGE Healthcare20230—
+4K222662Vitrea CT Cardiac AnalysisCanon Medical Informatics, Inc.20220—
+4K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+4K201583SmartCT R1.0Philips Medical Systems Nederland B.V.20211—
+4K202700ART-PlanTherapanacea20215—
+4K200899Quantib AI NodeQuantib B.V.20200—
+4K200179Collaboration LivePhilips Health Care20204—