510(k) Report

Devices descending from K974367

355 later devices reach Advantx LCN, Advantx LCLP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060259Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC2006474
+1K983877Philips Integris 3D RA OptionPhilips Medical Systems North America, Inc.1998328—
+2K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+2K091658GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova 4100, 3100…GE Healthcare2009111
+2K081582Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C2008231
+2K061163Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ…Ge Medical Systems, LLC20062238
+2K040254Integris 3D-RA, Release 4.2Philips Medical Systems North America Co.200484—
+2K011447IN Space 3DSiemens Medical Solutions USA, Inc.2001244—
+3K121772Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1Philips Medical Systems Nederland B.V.201315—
+3K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+3K121292Dynapbv Body SoftwareSiemens Medical Solutions USA, Inc.20120—
+3K113027Syngo Aortic Valveguide SoftwareSiemens Medical Solutions USA, Inc.2011151
+3K112054Infinix CF-I/SP and Infinix VF-I/SP Model Infx-8000VToshiba Medical Systems Corporation, Japan20110—
+3K111209Integrated Innova - S5I System OptionGE Healthcare201182
+3K110256The IC-Pro SystemPaieon, Inc.201115—
+3K111052Syngo Neuro PBV-IRSiemens Medical Solutions USA, Inc.20111—
+3K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+3K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C201021—
+3K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+3K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+3K062650EP Navigator SoftwarePhilips Medical Systems200649—
+3K043469Syngo Inspace 4DSiemens AG Medical Solutions2005218—
+3K042334Allura 3D-CA, Release 1Philips Medical Systems North America Co.200451—
+4K201583SmartCT R1.0Philips Medical Systems Nederland B.V.20211—
+4K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+4K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+4K170130Dynamic Coronary RoadmapPhilips Medical Systems Nederland B.V.20171—
+4K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+4K163622Lung VisionBodyvision Medical, Ltd.20176—
+4K160147CT TrueViewPhilips Medical Systems Nederland B.V.20160—
+4K151598VesselNavigator Rel. 1.0Philips Medical Systems Nederland B.V.20158—
+4K142273EmboGuidePhilips Medical Systems Nederland B.V.20151—
+4K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+4K133993Caas WorkstationPie Medical Imaging201410—
+4K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+4K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare2013520
+4K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+4K120282CardnavPaieon, Inc.20120—
+4K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+4K113594C-THV SystemPaieon, Inc.20120—
+4K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+4K113076Caas a-ValvePie Medical Imaging BV20121—
+4K120073Infx-8000V withToshibamedical Systems Corporation2012203
+4K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+4K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+4K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+4K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+4K071513Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions2007210—
+4K062351Syngo Dual EnergySiemens Medical Solutions USA, Inc.2006169—
+4K062673Modification to Syngo Inspace 4DSiemens AG Medical Solutions2006172—
+4K053024Syngo Neuro Dsa CTSiemens AG20058—
+5K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.20260—
+5K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+5K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+5K213479D²RS and D²RS 9090Stephanix20211—
+5K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+5K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+5K200887AS-10Canon, Inc.20200—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare201836
+5K172418OpenSightNovarad Corporation20185—
+5K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+5K172307Dynamic Coronary Roadmap 2.0Philips Medical Systems Nederland B.V.20170—
+5K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+5K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+5K160088Cydar EVCydar, Ltd.20167—
+5K151780CAAS WorkstationPie Medical Imaging BV20169—
+5K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+5K143044CAAS A-ValvePie Medical Imaging BV20150—
+5K133535Infx-8000V, V5.30Toshibamedical Systems Corporation2014102
+5K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+5K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+5K133278Discovery Igs 740GE Medical Systems SCS201445
+5K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+5K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C20138—
+5K123540Syngo CT Pulmo 3DSiemens Medical Systems, Inc.20139—
+5K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+5K123920Syngo.ViaSiemens AG Medical Solutions201363—
+5K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+5K113715Lung Volume AnalysisToshibamedical Systems Corporation20120—
+5K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+5K111079Syngo.Via Web ViewerSiemens AG Medical Solutions20111—
+5K103480Thoracic VcarGe Medical Systems, LLC20114—
+5K083227Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc.200849—
+5K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc.2008168—
+5K063507Syngo Neuro PBV CTSiemens AG20060—
+6K252503Intelligent NRCanon, Inc.20260—
+6K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+6K243884TavipilotCaranx Medical20250—
+6K2434463DXRGE Medical Systems SCS20250—
+6K241440HealthCCSngNano-X AI, Ltd.20240—
+6K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+6K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS202317
+6K223261Open RibCanon Medical Informatics, Inc.20230—
+6K222998F3Acrew Imaging, Inc.20230—
+6K230112CAC SoftwareImbio, Inc.20230—
+6K230223iCAC DeviceBunkerhill, Inc.20236—
+6K221796Cyware 4H and Cysart 4HAbys Medical20221—
+6K223071Xenoview VDPPolarean, Inc.20220—
+6K213128IntraOp VSP Software DeviceXironetic, LLC20221—