510(k) Report

Devices descending from K913770

1,148 later devices reach Advantage V.S. CT/MR Rad Diagnostic Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+10K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+10K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+10K213628VBrainVysioneer, Inc.20210—
+10K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+10K212116VBrain-OARVysioneer, Inc.20211—
+10K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+10K2116563D Echo v1.1Jointvue, LLC20210—
+10K2103452MP Monochrome LCD Monitor MS-S200Jvckenwood Corporation20210—
+10K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+10K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+10K203669Mobius3DVarian Medical Systems, Inc.20213—
+10K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+10K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+10K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+10K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+10K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+10K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+10K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+10K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+10K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+10K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+10K192455Merge PACSMerge Healthcare Incorporated201904
+10K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+10K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+10K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+10K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+10K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+10K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+10K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+10K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+10K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+10K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+10K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+10K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+10K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+10K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+10K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+10K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+10K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+10K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+10K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+11K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+11K253835AffinityHermes Medical Solutions AB20260—
+11K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation20260—
+11K260528OncoStudioOncosoft. Inc.,20260—
+11K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+11K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+11K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+11K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+11K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+11K251577Laia XRAugmented Reality Software S.L.20260—
+11K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+11K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+11K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+11K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+11K250955XC11 ICE System, USAYorlabs, Inc.20250—
+11K243685MammoScreen BDTherapixel20250—
+11K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PADBrainlab AG20250—
+11K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—
+11K244012Mosaic (V1.0.1)Navier Medical20250—
+11K243301MapRTVision Rt, Ltd.20250—
+11K250099Mobius3D (4.1)Varian Medical Systems20250—
+11K242925MR Contour DLGE Healthcare20250—
+11K240094LumiNE US; LumiAugmedit B.V.20240—
+11K241211CoLumboSmart Soft Healthcare20242—
+11K231765Contour ProtégéAIMim Software, Inc.20232—
+11K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+11K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+11K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+11K223834AccuCheckManteia Technologies Co., Ltd.20231—
+11K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+11K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+11K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+11K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+11K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+11K220497CoLumboSmart Soft Healthcare AD20226—
+11K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+11K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+11K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+11K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+11K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+11K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+11K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+11K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+11K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+11K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+11K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+11K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+11K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+11K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+11K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+11K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+11K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+11K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+11K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+11K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+11K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+11K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+11K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—