510(k) Report

Devices descending from K020483

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+8K243705Saige-Density (2.5.0)DeepHealth, Inc.20240—
+8K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+8K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+8K241837Limbus ContourLimbus Ai, Inc.20240—
+8K241561MammoScreen BDTherapixel20241—
+8K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+8K240620Cube NavigatorMedical Templates AG20240—
+8K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+8K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+8K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+8K233634TeleScanBb Imaging20230—
+8K230249IkshanaImmersivetouch20231—
+8K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+8K231185MapRTVision Rt, Ltd.20231—
+8K230082Auto SegmentationGe Medical Systems, LLC20231—
+8K221870CarnaLife HoloMedapp S.A.20230—
+8K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+8K223774Contour ProtégéAIMim Software, Inc.20233—
+8K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+8K221706AccuContourManteia Technologies Co., Ltd.20232—
+8K220630TorchTM SoftwareVoximetry, Incorporated20221—
+8K213215VSI HoloMedicineApoqlar GmbH20222—
+8K222070EndoNautTherenva Sas20221—
+8K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+8K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+8K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+8K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+8K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+8K213628VBrainVysioneer, Inc.20210—
+8K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+8K212116VBrain-OARVysioneer, Inc.20211—
+8K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+8K2116563D Echo v1.1Jointvue, LLC20210—
+8K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+8K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+8K203669Mobius3DVarian Medical Systems, Inc.20213—
+8K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+8K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+8K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+8K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+8K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+8K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+8K192437Arterys MICAArterys, Inc.20202—
+8K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+8K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+8K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+8K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+8K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+8K192455Merge PACSMerge Healthcare Incorporated201904
+8K191530StoneCheckerImaging Biometrics, LLC20191—
+8K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+8K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+8K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+8K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+8K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+8K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+8K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+8K180867AmCAD-UOAmcad Biomed Corporation20180—
+8K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+8K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+8K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+8K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+8K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+8K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+8K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+8K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+8K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+8K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+8K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+8K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+8K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+8K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+8K160371NovaPACSNovarad Corporation20165—
+8K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+8K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+8K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+8K151988Visible Patient SuiteVisible Patient, Sas20154—
+8K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+8K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+8K151233MonacoImpac Medical Systems, Inc.201569
+8K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+8K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+8K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+9K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+9K253835AffinityHermes Medical Solutions AB20260—
+9K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation20260—
+9K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+9K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+9K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+9K251577Laia XRAugmented Reality Software S.L.20260—
+9K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+9K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+9K250955XC11 ICE System, USAYorlabs, Inc.20250—
+9K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+9K243685MammoScreen BDTherapixel20250—
+9K252362GBrain MRIGalileo Cds, Inc.20250—
+9K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+9K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PADBrainlab AG20250—
+9K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I