510(k) Report

Devices descending from K942120

1,037 later devices reach Advantage Windows Diagnostic X-Ray Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+9K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+9K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+9K132853NovapacsNovarad Corp.201462
+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—
+9K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+9K13351121.3 Inch (54 CM) Monochrome LCD Monitor MS25I2(ML21025)Jvckenwood Corporation20131—
+9K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+9K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+9K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+9K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+9K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+10K261465Indira Cloud ViewerIndigo Technologies20260—
+10K253884Koios DS (3.8)Koios Medical, Inc.20260—
+10K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+10K261519Sonio SuspectSonio20260—
+10K253078ART.1-USSeetreat Pty, 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
+10K252922Neosoma Brain MetsNeosoma, Inc.20250—
+10K251883MIM – LesionID ProMim Software, Inc.20250—
+10K252294Fetal EchoScan (v1.2)Brightheart20250—
+10K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+10K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+10K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+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—
+10K243509Archer PSI System3D-Side20250—
+10K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+10K251071Fetal EchoScan (v1.1)Brightheart20251—
+10K250416GBrain MRIGalileo Cds, Inc.20251—
+10K243769QFR (3.0)Qfr Solutions BV20250—
+10K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+10K243705Saige-Density (2.5.0)DeepHealth, Inc.20240—
+10K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+10K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+10K241837Limbus ContourLimbus Ai, Inc.20240—
+10K241561MammoScreen BDTherapixel20241—
+10K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+10K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+10K240620Cube NavigatorMedical Templates AG20240—
+10K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+10K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+10K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+10K233634TeleScanBb Imaging20230—
+10K230249IkshanaImmersivetouch20231—
+10K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+10K231185MapRTVision Rt, Ltd.20231—
+10K230082Auto SegmentationGe Medical Systems, LLC20231—
+10K221870CarnaLife HoloMedapp S.A.20230—
+10K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+10K223774Contour ProtégéAIMim Software, Inc.20233—
+10K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+10K221706AccuContourManteia Technologies Co., Ltd.20232—
+10K220630TorchTM SoftwareVoximetry, Incorporated20221—
+10K213215VSI HoloMedicineApoqlar GmbH20222—
+10K222070EndoNautTherenva Sas20221—
+10K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+10K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+10K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+10K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+10K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+10K213628VBrainVysioneer, Inc.20210—
+10K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+10K212116VBrain-OARVysioneer, Inc.20211—
+10K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+10K2116563D Echo v1.1Jointvue, LLC20210—
+10K2103452MP Monochrome LCD Monitor MS-S200Jvckenwood Corporation20210—
+10K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+10K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+10K203669Mobius3DVarian Medical Systems, Inc.20213—
+10K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+10K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+10K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+10K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+10K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+10K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+10K192437Arterys MICAArterys, Inc.20202—
+10K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+10K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+10K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+10K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+10K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+10K192455Merge PACSMerge Healthcare Incorporated201904
+10K191530StoneCheckerImaging Biometrics, LLC20191—
+10K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+10K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+10K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+10K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+10K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+10K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+10K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+10K180867AmCAD-UOAmcad Biomed Corporation20180—
+10K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+10K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—