510(k) Report

Devices descending from K960613

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K11344321.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023)Totoku Electric Co., Ltd.20112—
+7K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+7K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+7K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+7K083691BonevueMicromri, Inc.20090—
+7K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+7K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+7K072821Vitrea 4DCTVital Images, Inc.2008171
+8K260597Virtue QAProNova Solutions20260—
+8K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+8K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+8K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+8K254161Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+8K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K252500CARA SystemCara Medical, Ltd.20260—
+8K252029AI-CVDHeartLung Corporation20250—
+8K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+8K251355X1-FFRSpectrawave, Inc.20250—
+8K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+8K250181AV ViewerPhilips Medical Systems Nederland B.V.20251—
+8K251766TumorSight VizSimBioSys, Inc.20250—
+8K242919V5med Lung AIV5med, Inc.20250—
+8K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+8K243614Sonio SuspectSonio20251—
+8K242130Koios DSKoios Medical, Inc.20241—
+8K242342Fetal EchoScanBrightheart20242—
+8K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+8K241245EchoSolv ASEcho IQ, Ltd.20240—
+8K240036PIUR tUS InfinityPiur Imaging GmbH20241—
+8K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+8K241302SonoSyncSamsung Medison Co., Ltd.20240—
+8K234141AISAP Cardio V1.0Aisap20240—
+8K240281Bone Suppression SoftwareKonica Minolta, Inc.20240—
+8K232147CAAS WorkstationPie Medical Imaging BV20241—
+8K232479ART-PlanTherapanacea20232—
+8K232096Transpara Density 1.0.0Screenpoint Medical B.V.20230—
+8K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+8K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+8K230575Limbus ContourLimbus Ai, Inc.20231—
+8K222275Saige-DensityDeepHealth, Inc.20221—
+8K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+8K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+8K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+8K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+8K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+8K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+8K212915MVision AI SegmentationMVision AI20221—
+8K220767TeleScanBb Imaging20221—
+8K213976Contour ProtégéAIMim Software, Inc.20224—
+8K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+8K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+8K210831OnQ NeuroCortechs Labs, Inc.20213—
+8K212887RTappSegana, Inc.20210—
+8K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+8K212383EndoNautTherenva Sas20212—
+8K211279Volpara Imaging SoftwareVolpara Health Technologies Limited20210—
+8K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+8K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+8K202928DV. TargetDeepvoxel, Inc.20210—
+8K203235VBrainVysioneer, Inc.20214—
+8K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.20202—
+8K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+8K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+8K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+8K2001613MP Monochrome Digital Mammography LCD Monitor MS-S300Jvckenwood Corporation20200—
+8K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+8K190868Cleerly LabsCleerly, Inc.20197—
+8K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+8K192424Mobius3DVarian Medical Systems, Inc.20194—
+8K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+8K190764SurgicalARMedivis, Inc.20196—
+8K190232Synapse PACSFujifilm Corporation2019311
+8K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+8K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+8K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+8K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+8K183012vascuCAPElucid Bioimaging, Inc.20182—
+8K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+8K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+8K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+8K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+8K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+8K182034Arterys MICAArterys, Inc.20183—
+8K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+8K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+8K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+8K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+8K1808835D ViewerSamsung Medison Co., Ltd.20180—
+8K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+8K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+8K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+8K173475Merge PACSMerge Healthcare Incorporated201712
+8K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+8K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+8K1725133D EchoJointvue, LLC20171—
+8K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+8K163668SuitestensaEbit Srl20170—
+8K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+8K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+8K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—