510(k) Report

Devices descending from K020483

872 later devices reach Advantage Workstation 4.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K222275Saige-DensityDeepHealth, Inc.20221—
+7K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+7K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+7K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+7K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+7K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+7K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+7K212915MVision AI SegmentationMVision AI20221—
+7K220767TeleScanBb Imaging20221—
+7K213976Contour ProtégéAIMim Software, Inc.20224—
+7K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+7K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+7K210831OnQ NeuroCortechs Labs, Inc.20213—
+7K212887RTappSegana, Inc.20210—
+7K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+7K212383EndoNautTherenva Sas20212—
+7K211279Volpara Imaging SoftwareVolpara Health Technologies Limited20210—
+7K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+7K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+7K202928DV. TargetDeepvoxel, Inc.20210—
+7K203235VBrainVysioneer, Inc.20214—
+7K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.20202—
+7K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+7K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+7K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+7K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+7K190868Cleerly LabsCleerly, Inc.20197—
+7K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+7K192424Mobius3DVarian Medical Systems, Inc.20194—
+7K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+7K190764SurgicalARMedivis, Inc.20196—
+7K190232Synapse PACSFujifilm Corporation2019311
+7K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+7K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+7K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+7K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+7K183012vascuCAPElucid Bioimaging, Inc.20182—
+7K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+7K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+7K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+7K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+7K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+7K182034Arterys MICAArterys, Inc.20183—
+7K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+7K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+7K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+7K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+7K1808835D ViewerSamsung Medison Co., Ltd.20180—
+7K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+7K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+7K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+7K173475Merge PACSMerge Healthcare Incorporated201712
+7K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+7K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+7K1725133D EchoJointvue, LLC20171—
+7K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+7K163668SuitestensaEbit Srl20170—
+7K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+7K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+7K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+7K160937SenolrisGE Healthcare20160—
+7K153289HealthmyneHealthmyne, Inc.20160—
+7K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+7K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+7K150843syngo®.via (version VB10A)Siemens AG201546—
+7K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+7K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+7K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+7K132853NovapacsNovarad Corp.201462
+7K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+7K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+7K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+7K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+7K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+7K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+7K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+7K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+7K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+8K261465Indira Cloud ViewerIndigo Technologies20260—
+8K253884Koios DS (3.8)Koios Medical, Inc.20260—
+8K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+8K261519Sonio SuspectSonio20260—
+8K253078ART.1-USSeetreat Pty, Ltd.20260—
+8K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+8K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+8K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+8K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202611
+8K252922Neosoma Brain MetsNeosoma, Inc.20250—
+8K251883MIM – LesionID ProMim Software, Inc.20250—
+8K252294Fetal EchoScan (v1.2)Brightheart20250—
+8K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+8K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+8K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+8K250484PIUR tUS insidePiur Imaging GmbH20250—
+8K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+8K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+8K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+8K251071Fetal EchoScan (v1.1)Brightheart20251—
+8K250416GBrain MRIGalileo Cds, Inc.20251—
+8K243769QFR (3.0)Qfr Solutions BV20250—