510(k) Report

Devices descending from K960613

914 later devices reach GE Advantage Windows Review Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K160937SenolrisGE Healthcare20160—
+8K153289HealthmyneHealthmyne, Inc.20160—
+8K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+8K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+8K150843syngo®.via (version VB10A)Siemens AG201546—
+8K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+8K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+8K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+8K132853NovapacsNovarad Corp.201462
+8K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+8K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+8K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+8K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+8K13351121.3 Inch (54 CM) Monochrome LCD Monitor MS25I2(ML21025)Jvckenwood Corporation20131—
+8K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+8K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+8K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+8K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+8K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+9K261465Indira Cloud ViewerIndigo Technologies20260—
+9K253884Koios DS (3.8)Koios Medical, Inc.20260—
+9K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+9K261519Sonio SuspectSonio20260—
+9K253078ART.1-USSeetreat Pty, Ltd.20260—
+9K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+9K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+9K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+9K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202611
+9K252922Neosoma Brain MetsNeosoma, Inc.20250—
+9K251883MIM – LesionID ProMim Software, Inc.20250—
+9K252294Fetal EchoScan (v1.2)Brightheart20250—
+9K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+9K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+9K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+9K250484PIUR tUS insidePiur Imaging GmbH20250—
+9K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+9K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+9K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+9K251071Fetal EchoScan (v1.1)Brightheart20251—
+9K250416GBrain MRIGalileo Cds, Inc.20251—
+9K243769QFR (3.0)Qfr Solutions BV20250—
+9K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+9K243705Saige-Density (2.5.0)DeepHealth, Inc.20240—
+9K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+9K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+9K241837Limbus ContourLimbus Ai, Inc.20240—
+9K241561MammoScreen BDTherapixel20241—
+9K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+9K240620Cube NavigatorMedical Templates AG20240—
+9K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+9K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+9K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+9K233634TeleScanBb Imaging20230—
+9K230249IkshanaImmersivetouch20231—
+9K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+9K231185MapRTVision Rt, Ltd.20231—
+9K230082Auto SegmentationGe Medical Systems, LLC20231—
+9K221870CarnaLife HoloMedapp S.A.20230—
+9K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+9K223774Contour ProtégéAIMim Software, Inc.20233—
+9K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+9K221706AccuContourManteia Technologies Co., Ltd.20232—
+9K220630TorchTM SoftwareVoximetry, Incorporated20221—
+9K213215VSI HoloMedicineApoqlar GmbH20222—
+9K222070EndoNautTherenva Sas20221—
+9K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+9K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+9K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+9K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+9K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+9K213628VBrainVysioneer, Inc.20210—
+9K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+9K212116VBrain-OARVysioneer, Inc.20211—
+9K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+9K2116563D Echo v1.1Jointvue, LLC20210—
+9K2103452MP Monochrome LCD Monitor MS-S200Jvckenwood Corporation20210—
+9K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+9K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+9K203669Mobius3DVarian Medical Systems, Inc.20213—
+9K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+9K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+9K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+9K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+9K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+9K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+9K192437Arterys MICAArterys, Inc.20202—
+9K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+9K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+9K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+9K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+9K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+9K192455Merge PACSMerge Healthcare Incorporated201904
+9K191530StoneCheckerImaging Biometrics, LLC20191—
+9K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+9K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+9K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+9K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+9K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+9K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+9K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—