510(k) Report

Devices descending from K983877

328 later devices reach Philips Integris 3D RA Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040254Integris 3D-RA, Release 4.2Philips Medical Systems North America Co.200484—
+1K011447IN Space 3DSiemens Medical Solutions USA, Inc.2001244—
+2K121772Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1Philips Medical Systems Nederland B.V.201315—
+2K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+2K121292Dynapbv Body SoftwareSiemens Medical Solutions USA, Inc.20120—
+2K113027Syngo Aortic Valveguide SoftwareSiemens Medical Solutions USA, Inc.2011151
+2K110256The IC-Pro SystemPaieon, Inc.201115—
+2K111052Syngo Neuro PBV-IRSiemens Medical Solutions USA, Inc.20111—
+2K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+2K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C201021—
+2K062650EP Navigator SoftwarePhilips Medical Systems200649—
+2K043469Syngo Inspace 4DSiemens AG Medical Solutions2005218—
+2K042334Allura 3D-CA, Release 1Philips Medical Systems North America Co.200451—
+3K201583SmartCT R1.0Philips Medical Systems Nederland B.V.20211—
+3K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+3K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+3K170130Dynamic Coronary RoadmapPhilips Medical Systems Nederland B.V.20171—
+3K163622Lung VisionBodyvision Medical, Ltd.20176—
+3K160147CT TrueViewPhilips Medical Systems Nederland B.V.20160—
+3K151598VesselNavigator Rel. 1.0Philips Medical Systems Nederland B.V.20158—
+3K142273EmboGuidePhilips Medical Systems Nederland B.V.20151—
+3K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+3K133993Caas WorkstationPie Medical Imaging201410—
+3K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+3K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+3K120282CardnavPaieon, Inc.20120—
+3K113594C-THV SystemPaieon, Inc.20120—
+3K113076Caas a-ValvePie Medical Imaging BV20121—
+3K120073Infx-8000V withToshibamedical Systems Corporation2012203
+3K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+3K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+3K071513Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions2007210—
+3K062351Syngo Dual EnergySiemens Medical Solutions USA, Inc.2006169—
+3K062673Modification to Syngo Inspace 4DSiemens AG Medical Solutions2006172—
+3K053024Syngo Neuro Dsa CTSiemens AG20058—
+4K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.20260—
+4K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+4K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+4K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+4K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+4K172418OpenSightNovarad Corporation20185—
+4K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+4K172307Dynamic Coronary Roadmap 2.0Philips Medical Systems Nederland B.V.20170—
+4K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+4K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+4K160088Cydar EVCydar, Ltd.20167—
+4K151780CAAS WorkstationPie Medical Imaging BV20169—
+4K143044CAAS A-ValvePie Medical Imaging BV20150—
+4K133535Infx-8000V, V5.30Toshibamedical Systems Corporation2014102
+4K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+4K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+4K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+4K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C20138—
+4K123540Syngo CT Pulmo 3DSiemens Medical Systems, Inc.20139—
+4K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+4K123920Syngo.ViaSiemens AG Medical Solutions201363—
+4K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+4K113715Lung Volume AnalysisToshibamedical Systems Corporation20120—
+4K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+4K111079Syngo.Via Web ViewerSiemens AG Medical Solutions20111—
+4K103480Thoracic VcarGe Medical Systems, LLC20114—
+4K083227Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc.200849—
+4K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc.2008168—
+4K063507Syngo Neuro PBV CTSiemens AG20060—
+5K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+5K243884TavipilotCaranx Medical20250—
+5K241440HealthCCSngNano-X AI, Ltd.20240—
+5K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+5K223261Open RibCanon Medical Informatics, Inc.20230—
+5K222998F3Acrew Imaging, Inc.20230—
+5K230112CAC SoftwareImbio, Inc.20230—
+5K230223iCAC DeviceBunkerhill, Inc.20236—
+5K221796Cyware 4H and Cysart 4HAbys Medical20221—
+5K223071Xenoview VDPPolarean, Inc.20220—
+5K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+5K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+5K220146VisARNovarad Corporation20220—
+5K203783ClariPulmoClaripi, Inc.20220—
+5K220450syngo.CT ApplicationsSiemens Medical Solutions USA, Inc.20221—
+5K212442Cydar EV (Series B) and Cydar EV MapsCydar, Ltd.20211—
+5K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+5K200990VIDAvisionVida Diagnostics, Inc.20202—
+5K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+5K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+5K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+5K191550BroncholabFluidda, Inc.20200—
+5K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+5K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+5K183210Thoracic VCAR with GSI Pulmonary PerfusionGE Medical Systems SCS20190—
+5K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+5K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+5K173821LungQ SoftwareThirona Corporation20183—
+5K180019CAAS WorkstationPie Medical Imaging BV20188—
+5K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+5K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+5K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+5K171829EndoNautTherenva Sas20173—
+5K151919Vitrea CT Lung Density Analysis SoftwareVital Images, Inc.201510—
+5K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+5K143294Adaptive Motion Correction (AMC), CSMC-001A and 4D AirwaysToshibamedical Systems Corporation20150—