510(k) Report

Devices descending from K974715

298 later devices reach Advantage 3D XR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052412Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQGE Healthcare20057450
+1K9846343D-AngioSiemens Medical Corp.1999245—
+2K152352Stereo 3D option for Vision ApplicationsGE Medical Systems SCS20161—
+2K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C201021—
+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
+2K081624Infx-8000F (Infinix Csi and Infinix Dpi)Toshiba America Medical Systems, In.C2008138
+2K081621Infx-8000C (Infinix CC-I and VC-I)Toshiba America Medical Systems, In.C2008101
+2K061163Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ…Ge Medical Systems, LLC20062238
+2K060259Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC2006474
+2K011447IN Space 3DSiemens Medical Solutions USA, Inc.2001244—
+3K223152Vision 2, EVARVision, TrackVision 2, HeartVision 2GE Medical Systems SCS20220—
+3K182415Alphenix, INFX-8000F/B, V8.0Canon Medical Systems Corporation201805
+3K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+3K121292Dynapbv Body SoftwareSiemens Medical Solutions USA, Inc.20120—
+3K120073Infx-8000V withToshibamedical Systems Corporation2012203
+3K113027Syngo Aortic Valveguide SoftwareSiemens Medical Solutions USA, Inc.2011151
+3K113052Infinix-CciToshiba America Medical Systems, In.C201171
+3K111209Integrated Innova - S5I System OptionGE Healthcare201182
+3K111052Syngo Neuro PBV-IRSiemens Medical Solutions USA, Inc.20111—
+3K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+3K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+3K082830Infx-8000H, Infinix-IToshiba America Medical Systems, In.C200812
+3K081582Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C2008231
+3K043469Syngo Inspace 4DSiemens AG Medical Solutions2005218—
+4K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+4K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+4K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+4K182546Alphenix, INFX-8000H/B, V8.0Canon Medical Systems Corporation201802
+4K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+4K152697Infx-8000C, V6.20Toshibamedical Systems Corporation201635
+4K143223CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation20152—
+4K134025Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation20143—
+4K133535Infx-8000V, V5.30Toshibamedical Systems Corporation2014102
+4K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C20138—
+4K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare2013520
+4K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+4K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+4K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+4K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+4K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+4K112054Infinix CF-I/SP and Infinix VF-I/SP Model Infx-8000VToshiba Medical Systems Corporation, Japan20110—
+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—
+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—
+5K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+5K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare201836
+5K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ACanon Medical Systems, USA20181—
+5K181804Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation201823
+5K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+5K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+5K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+5K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+5K143225INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation201592
+5K141541Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation20147—
+5K133278Discovery Igs 740GE Medical Systems SCS201445
+5K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+5K123540Syngo CT Pulmo 3DSiemens Medical Systems, Inc.20139—
+5K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+5K123920Syngo.ViaSiemens AG Medical Solutions201363—
+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—
+6K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+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—
+6K230112CAC SoftwareImbio, Inc.20230—
+6K230223iCAC DeviceBunkerhill, Inc.20236—
+6K223071Xenoview VDPPolarean, Inc.20220—
+6K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+6K221335D²RS and D²RS 9090Stephanix20220—
+6K203783ClariPulmoClaripi, Inc.20220—
+6K220450syngo.CT ApplicationsSiemens Medical Solutions USA, Inc.20221—
+6K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+6K210900Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation202117
+6K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+6K200990VIDAvisionVida Diagnostics, Inc.20202—
+6K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+6K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+6K191550BroncholabFluidda, Inc.20200—
+6K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+6K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+6K183210Thoracic VCAR with GSI Pulmonary PerfusionGE Medical Systems SCS20190—