510(k) Report

Devices descending from K960613

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K180867AmCAD-UOAmcad Biomed Corporation20180—
+9K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+9K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+9K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+9K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+9K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+9K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+9K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+9K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+9K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+9K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+9K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+9K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+9K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+9K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+9K160371NovaPACSNovarad Corporation20165—
+9K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+9K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+9K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+9K151988Visible Patient SuiteVisible Patient, Sas20154—
+9K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+9K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+9K151233MonacoImpac Medical Systems, Inc.201569
+9K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+9K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+9K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+10K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+10K253835AffinityHermes Medical Solutions AB20260—
+10K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation20260—
+10K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+10K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+10K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+10K251577Laia XRAugmented Reality Software S.L.20260—
+10K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+10K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+10K250955XC11 ICE System, USAYorlabs, Inc.20250—
+10K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+10K243685MammoScreen BDTherapixel20250—
+10K252362GBrain MRIGalileo Cds, Inc.20250—
+10K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+10K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PADBrainlab AG20250—
+10K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+10K244012Mosaic (V1.0.1)Navier Medical20250—
+10K243301MapRTVision Rt, Ltd.20250—
+10K250099Mobius3D (4.1)Varian Medical Systems20250—
+10K242925MR Contour DLGE Healthcare20250—
+10K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+10K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+10K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+10K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+10K240094LumiNE US; LumiAugmedit B.V.20240—
+10K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+10K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+10K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+10K231765Contour ProtégéAIMim Software, Inc.20232—
+10K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+10K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+10K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+10K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+10K223834AccuCheckManteia Technologies Co., Ltd.20231—
+10K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+10K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+10K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+10K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+10K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+10K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+10K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+10K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+10K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+10K203744Arterys MICAArterys, Inc.20221—
+10K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+10K212896Visible Patient SuiteVisible Patient, Sas20213—
+10K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+10K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+10K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+10K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+10K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+10K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+10K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+10K202084DeepLook PRECISEDeeplook, Inc.20210—
+10K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+10K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+10K201948AcroDTI VisualizerAcroviz, Inc.20200—
+10K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+10K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+10K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+10K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+10K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+10K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+10K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+10K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+10K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+10K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+10K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+10K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+10K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+10K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+10K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+10K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+10K183037Monaco RTP SystemElekta, Inc.201856