510(k) Report

Devices descending from K954355

758 later devices reach Advantage Windows 3D with Navigator Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+8K231683inHEART ModelsInheart, Sas20240—
+8K232412LungQ v3.0.0Thirona BV20241—
+8K232136syngo.CT ApplicationsSiemens Medical Solutions USA, Inc.20240—
+8K232479ART-PlanTherapanacea20232—
+8K232392CT Lung Ventilation Analysis Software (CT:V)4Dmedical Limited20231—
+8K223834AccuCheckManteia Technologies Co., Ltd.20231—
+8K223424Spine Auto ViewsGE Medical Systems SCS20230—
+8K223556DeepCatchMedical IP Co., Ltd.20231—
+8K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+8K220349TeraRecon NeuroTerarecon,Inc.20220—
+8K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+8K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+8K213944HealthOSTNanoxai, Ltd.20221—
+8K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+8K213976Contour ProtégéAIMim Software, Inc.20224—
+8K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+8K212777Collaboration LivePhilips Ultrasound, Inc.20211—
+8K212421ADAS 3DAdas3D Medical S.L.20213—
+8K212494Lung Image AnalysisPulmonx Corporation20210—
+8K212383EndoNautTherenva Sas20212—
+8K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+8K193293XV Lung Ventilation Analysis Software4Dx Limited20200—
+8K192437Arterys MICAArterys, Inc.20202—
+8K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+8K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+8K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+8K190178Monaco RTP SystemElekta, Inc.201945
+8K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+8K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+8K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+8K171199AVIEWCoreline Soft Co., Ltd.20186—
+8K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+8K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+8K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+8K1808835D ViewerSamsung Medison Co., Ltd.20180—
+8K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+8K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+8K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+8K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+8K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+8K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+8K171754NovaPACSNovarad Corporation201741
+8K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+8K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+8K163539Ez3D-i / E3Ewoosoft Co., Ltd.20161—
+8K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation20167—
+8K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+8K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+8K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+9K260528OncoStudioOncosoft. Inc.,20260—
+9K253078ART.1-USSeetreat Pty, Ltd.20260—
+9K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+9K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+9K253944Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated20260—
+9K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+9K250696AccuCheckManteia Technologies Co., Ltd.20250—
+9K250766LungQ 4Thirona BV20250—
+9K251484CT:VQ4Dmedical Limited20250—
+9K252362GBrain MRIGalileo Cds, Inc.20250—
+9K251766TumorSight VizSimBioSys, Inc.20250—
+9K250484PIUR tUS insidePiur Imaging GmbH20250—
+9K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+9K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+9K242411Brainomix 360 e-LungBrainomix Limited20250—
+9K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+9K241302SonoSyncSamsung Medison Co., Ltd.20240—
+9K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+9K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+9K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+9K231662Aid-UIaid20241—
+9K233080HealthFLDNano-X AI, Ltd.20240—
+9K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+9K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+9K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+9K230803ADAS 3DAdas3D Medical S.L.20232—
+9K223774Contour ProtégéAIMim Software, Inc.20233—
+9K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+9K221796Cyware 4H and Cysart 4HAbys Medical20221—
+9K222070EndoNautTherenva Sas20221—
+9K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+9K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+9K203744Arterys MICAArterys, Inc.20221—
+9K202789Monaco Rtp SystemElekta Solutions AB20213—
+9K201948AcroDTI VisualizerAcroviz, Inc.20200—
+9K200714AVIEWCoreline Soft Co., Ltd.20205—
+9K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+9K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+9K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+9K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+9K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+9K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+9K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+9K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+9K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+9K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+9K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+9K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+9K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+9K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—