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
+9K2001613MP Monochrome Digital Mammography LCD Monitor MS-S300Jvckenwood Corporation20200—
+9K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+9K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+9K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+9K192424Mobius3DVarian Medical Systems, Inc.20194—
+9K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+9K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+9K190764SurgicalARMedivis, Inc.20196—
+9K190232Synapse PACSFujifilm Corporation2019311
+9K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+9K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+9K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+9K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+9K183012vascuCAPElucid Bioimaging, Inc.20182—
+9K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+9K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+9K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+9K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+9K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+9K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+9K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+9K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—
+9K1808835D ViewerSamsung Medison Co., Ltd.20180—
+9K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+9K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+9K173475Merge PACSMerge Healthcare Incorporated201712
+9K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+9K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+9K1725133D EchoJointvue, LLC20171—
+9K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+9K163668SuitestensaEbit Srl20170—
+9K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+9K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+9K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+9K160937SenolrisGE Healthcare20160—
+9K153289HealthmyneHealthmyne, Inc.20160—
+9K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+9K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+9K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+9K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+9K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+9K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+9K13351121.3 Inch (54 CM) Monochrome LCD Monitor MS25I2(ML21025)Jvckenwood Corporation20131—
+9K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+9K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+9K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+10K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+10K252571mdprostateMediaire GmbH20260—
+10K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+10K261210Cleerly PlaqueCleerly, Inc.20260—
+10K260588Cleerly LABSCleerly, Inc.20260—
+10K261465Indira Cloud ViewerIndigo Technologies20260—
+10K253884Koios DS (3.8)Koios Medical, Inc.20260—
+10K253969ADAS 3DAdas3D Medical S.L.20260—
+10K253690LungMapsSiemens Healthineers AG20260—
+10K261519Sonio SuspectSonio20260—
+10K253078ART.1-USSeetreat Pty, Ltd.20260—
+10K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+10K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+10K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+10K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+10K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202611
+10K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+10K252922Neosoma Brain MetsNeosoma, Inc.20250—
+10K252294Fetal EchoScan (v1.2)Brightheart20250—
+10K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+10K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+10K252362GBrain MRIGalileo Cds, Inc.20250—
+10K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+10K250484PIUR tUS insidePiur Imaging GmbH20250—
+10K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+10K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+10K251071Fetal EchoScan (v1.1)Brightheart20251—
+10K243769QFR (3.0)Qfr Solutions BV20250—
+10K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+10K243705Saige-Density (2.5.0)DeepHealth, Inc.20240—
+10K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+10K241837Limbus ContourLimbus Ai, Inc.20240—
+10K241561MammoScreen BDTherapixel20241—
+10K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+10K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+10K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+10K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+10K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+10K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+10K233634TeleScanBb Imaging20230—
+10K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+10K230249IkshanaImmersivetouch20231—
+10K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+10K231185MapRTVision Rt, Ltd.20231—
+10K230082Auto SegmentationGe Medical Systems, LLC20231—
+10K221870CarnaLife HoloMedapp S.A.20230—
+10K223774Contour ProtégéAIMim Software, Inc.20233—
+10K221706AccuContourManteia Technologies Co., Ltd.20232—
+10K223233Monaco RTP SystemElekta Solutions AB20231—
+10K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+10K220630TorchTM SoftwareVoximetry, Incorporated20221—
+10K213215VSI HoloMedicineApoqlar GmbH20222—
+10K222070EndoNautTherenva Sas20221—
+10K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—