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
+9K252500CARA SystemCara Medical, Ltd.20260—
+9K253639ViewGE Healthcare20260—
+9K253008maiLinkMaihub Corp.20260—
+9K252029AI-CVDHeartLung Corporation20250—
+9K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+9K251355X1-FFRSpectrawave, Inc.20250—
+9K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+9K250181AV ViewerPhilips Medical Systems Nederland B.V.20251—
+9K251766TumorSight VizSimBioSys, Inc.20250—
+9K242552Horos MobileIcat Solutions, Ltd.20250—
+9K242919V5med Lung AIV5med, Inc.20250—
+9K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+9K241546aiCockpit AI ViewerFovia, Inc.20250—
+9K243614Sonio SuspectSonio20251—
+9K242362Lightning ViewerNexsys Electronics Inc. Dba Medweb20240—
+9K242130Koios DSKoios Medical, Inc.20241—
+9K242342Fetal EchoScanBrightheart20242—
+9K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+9K241245EchoSolv ASEcho IQ, Ltd.20240—
+9K240036PIUR tUS InfinityPiur Imaging GmbH20241—
+9K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+9K241302SonoSyncSamsung Medison Co., Ltd.20240—
+9K234141AISAP Cardio V1.0Aisap20240—
+9K240281Bone Suppression SoftwareKonica Minolta, Inc.20240—
+9K232147CAAS WorkstationPie Medical Imaging BV20241—
+9K232479ART-PlanTherapanacea20232—
+9K232096Transpara Density 1.0.0Screenpoint Medical B.V.20230—
+9K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+9K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+9K230575Limbus ContourLimbus Ai, Inc.20231—
+9K230294CoverScan (CoverScan v1.1)Perspectum20230—
+9K222275Saige-DensityDeepHealth, Inc.20221—
+9K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+9K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+9K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+9K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+9K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+9K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+9K212915MVision AI SegmentationMVision AI20221—
+9K220767TeleScanBb Imaging20221—
+9K213976Contour ProtégéAIMim Software, Inc.20224—
+9K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+9K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+9K210831OnQ NeuroCortechs Labs, Inc.20213—
+9K212887RTappSegana, Inc.20210—
+9K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+9K212383EndoNautTherenva Sas20212—
+9K211279Volpara Imaging SoftwareVolpara Health Technologies Limited20210—
+9K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+9K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+9K202928DV. TargetDeepvoxel, Inc.20210—
+9K203235VBrainVysioneer, Inc.20214—
+9K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.20202—
+9K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+9K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+9K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+9K2001613MP Monochrome Digital Mammography LCD Monitor MS-S300Jvckenwood Corporation20200—
+9K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+9K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+9K190868Cleerly LabsCleerly, Inc.20197—
+9K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+9K192424Mobius3DVarian Medical Systems, Inc.20194—
+9K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+9K190764SurgicalARMedivis, Inc.20196—
+9K190232Synapse PACSFujifilm Corporation2019311
+9K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+9K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+9K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+9K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+9K183012vascuCAPElucid Bioimaging, Inc.20182—
+9K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+9K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+9K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+9K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+9K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+9K182034Arterys MICAArterys, Inc.20183—
+9K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+9K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+9K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+9K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+9K1808835D ViewerSamsung Medison Co., Ltd.20180—
+9K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+9K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+9K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+9K173475Merge PACSMerge Healthcare Incorporated201712
+9K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+9K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+9K1725133D EchoJointvue, LLC20171—
+9K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+9K163668SuitestensaEbit Srl20170—
+9K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+9K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+9K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+9K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+9K160937SenolrisGE Healthcare20160—
+9K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+9K153289HealthmyneHealthmyne, Inc.20160—
+9K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+9K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+9K150843syngo®.via (version VB10A)Siemens AG201546—