510(k) Report

Devices descending from K954355

758 later devices reach Advantage Windows 3D with Navigator Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061532Gentle Colon (Revision 2.0)Rendoscopy, Inc.20060—
+1K040126Viatronix V3D Colon, Revision 1.3Viatronix, Inc.20042—
+1K032483Viatronix V3D Explorer, Revision 1.2Viatronix, Inc.200376—
+1K022789Viatronix V3D ExplorerViatronix, Inc.20020—
+1K020658Viatronix V3D ColonViatronix, Inc.20024—
+1K012313CT Colonography/NAVIGATOR2Ge Medical Systems, Inc.20015801
+1K993792Smart Vessel Analysis (Smart VA) OptionGe Medical Systems, Inc.199960—
+1K974715Advantage 3D XRGE Medical Systems1998298—
+1K972399Advantage Windows Volume Rendering OptionGe Medical Systems, Inc.19975161
+1K962010Epi-Scope Option for Q Series CT SystemsPhilips Medical Systems (Cleveland), Inc.19979—
+2K123566Synapse 3D Colon AnalysisFujifilm Medical Systems U.S.A, Inc.20130—
+2K111758Cadens (TM) ColonDog Microsystems, Inc.20120—
+2K063221Medweb Advanced 3D Web PacsNexsys Electronics, Inc.20061—
+2K061372Centricity AW Suite OptionGe Healthcare Information Technologies200602
+2K060779Advance Vessel Analysis IIGE Healthcare200655—
+2K052412Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQGE Healthcare20057450
+2K041521Volume Viewer PlusGeneral Electric Medical Systems20044692
+2K033955RTISTMirada Solutions, Ltd.200475—
+2K033361Viatronix V3D Vascular, Revision 1.0Viatronix, Inc.200322—
+2K031871AutoboneGe Medical Systems Europe200358—
+2K023943CT ColonographyGe Medical Systems, Inc.20033—
+2K030982Syngo Colonography Software PackageSiemens Medical Solutions USA, Inc.2003227—
+2K990241Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze, Accuscope…Accuimage Diagnostics Corp.19998—
+2K9846343D-AngioSiemens Medical Corp.1999245—
+3K243651VersaViewerGE Medical Systems SCS20250—
+3K200626VesselIQ XpressGE Medical Systems SCS20210—
+3K163281FastStrokeGef Medical Systems Scs20172—
+3K152584Stroke VCARGE Medical Systems SCS20160—
+3K152352Stereo 3D option for Vision ApplicationsGE Medical Systems SCS20161—
+3K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+3K133649Hepatic VcarGE Medical Systems SCS20143—
+3K131498Iqqa-Liver Multimodality SoftwareEdda Technology, Inc.201316—
+3K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+3K121200Flightplan for LiverGE Healthcare20123—
+3K122164MR Vessellq XpressGE Medical Systems SCS20120—
+3K110573Ready ViewGe Healthcare (Ge Medical Systems Scs)2011381
+3K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C201021—
+3K101228Mirada XDMirada Medical, Ltd.201070—
+3K092639Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision…GE Medical Systems SCS200965—
+3K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+3K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+3K091658GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova 4100, 3100…GE Healthcare2009111
+3K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+3K090220Colon View, Model CSCV-001AToshibamedical Systems Corporation20090—
+3K082336XR-ExpressNew Mexico Software, Inc.20080—
+3K081215VoluminaKjaya Medical, LLC20080—
+3K081624Infx-8000F (Infinix Csi and Infinix Dpi)Toshiba America Medical Systems, In.C2008138
+3K081621Infx-8000C (Infinix CC-I and VC-I)Toshiba America Medical Systems, In.C2008101
+3K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC2008631
+3K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+3K063324Pet VcarGE Healthcare20072041
+3K070248VelocityaisVelocity Medical Solutions, LLC200765—
+3K061696Iqqa-Liver SoftwareEdda Technology, Inc.2006217—
+3K061418QuantivaTomographix IP, Ltd.20060—
+3K061625AUTOBONE2GE Healthcare20060—
+3K061163Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ…Ge Medical Systems, LLC20062238
+3K061370Cardiq FusionGE Healthcare200651—
+3K060840SVIEWMri Cardiac Services, Incorporated20060—
+3K060378VITREA2 Version 3.8.1Vital Images, Inc.20061—
+3K060259Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC2006474
+3K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+3K052995Advantage Workstation 4.3.GE Healthcare20051134
+3K052345Advantage Sim MDGE Healthcare2005213
+3K042605Colongraphy Software Package with Extended FunctionalitySiemens AG Medical Solutions200476—
+3K040782N-Vivo Calcium Score on IA Chassis Release, Model Release X.XXImage Analysis, Inc.20040—
+3K041270CT Colonography IIGeneral Electric Medical Systems20042—
+3K033102Medic Colon Model, Release 1Medicsight2003210—
+3K032546Hologic DR ImageproHologic, Inc.20030—
+3K024149PrimelungAccuimage Diagnostics Corp.20031—
+3K021913Calscor Software3D Med Co., Ltd.20020—
+3K011447IN Space 3DSiemens Medical Solutions USA, Inc.2001244—
+4K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+4K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+4K241543DrAid™ for Liver SegmentationVinbrain Joint Stock Company20240—
+4K240786AutoChamberHeartLung Corporation20241—
+4K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+4K240620Cube NavigatorMedical Templates AG20240—
+4K233572AutofusePymedix20240—
+4K231690iCAS-LVHighrad, Ltd.20240—
+4K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+4K223152Vision 2, EVARVision, TrackVision 2, HeartVision 2GE Medical Systems SCS20220—
+4K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+4K220779XDMirada Medical, Ltd.20220—
+4K210830VUZE SystemVuze Medical, Ltd.20221—
+4K210807FlightPlan for LiverGE Medical Systems SCS20210—
+4K211247Pet VcarGE Medical Systems SCS20211—
+4K193289FastStroke, CT Perfusion 4DGE Medical Systems SCS20201—
+4K201092LSNImaging Biometrics, LLC20200—
+4K193281Hepatic VCARGE Medical Systems SCS20201—
+4K193261FlightPlan for EmbolizationGE Medical Systems SCS20201—
+4K190868Cleerly LabsCleerly, Inc.20197—
+4K191530StoneCheckerImaging Biometrics, LLC20191—
+4K183133MRCP+ v1.0Perspectum Diagnostics, Ltd.20191—
+4K180867AmCAD-UOAmcad Biomed Corporation20180—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K182415Alphenix, INFX-8000F/B, V8.0Canon Medical Systems Corporation201805
+4K180522IGTFusionIgi Technologies20180—
+4K173636VelocityVarian Medical Systems, Inc.20188—
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—