510(k) Report

Devices descending from K920319

355 later devices reach Sienet Image Display Workstations, Image Acquisiti through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+8K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+8K250416GBrain MRIGalileo Cds, Inc.20251—
+8K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+8K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+8K241837Limbus ContourLimbus Ai, Inc.20240—
+8K233998TRAQinform IQAiq Global, Inc.20240—
+8K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+8K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+8K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+8K231185MapRTVision Rt, Ltd.20231—
+8K230082Auto SegmentationGe Medical Systems, LLC20231—
+8K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+8K223774Contour ProtégéAIMim Software, Inc.20233—
+8K221706AccuContourManteia Technologies Co., Ltd.20232—
+8K220630TorchTM SoftwareVoximetry, Incorporated20221—
+8K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+8K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+8K213628VBrainVysioneer, Inc.20210—
+8K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+8K212116VBrain-OARVysioneer, Inc.20211—
+8K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+8K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+8K203669Mobius3DVarian Medical Systems, Inc.20213—
+8K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+8K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+8K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+8K192455Merge PACSMerge Healthcare Incorporated201904
+8K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+8K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+8K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+8K181892Ziostation2Ziosoft, Inc.20181—
+8K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+8K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+8K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+8K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+8K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+8K151233MonacoImpac Medical Systems, Inc.201569
+8K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+9K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+9K253835AffinityHermes Medical Solutions AB20260—
+9K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation20260—
+9K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+9K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+9K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+9K252362GBrain MRIGalileo Cds, Inc.20250—
+9K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+9K243301MapRTVision Rt, Ltd.20250—
+9K250099Mobius3D (4.1)Varian Medical Systems20250—
+9K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+9K242925MR Contour DLGE Healthcare20250—
+9K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+9K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+9K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+9K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+9K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+9K231765Contour ProtégéAIMim Software, Inc.20232—
+9K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+9K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+9K223834AccuCheckManteia Technologies Co., Ltd.20231—
+9K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+9K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+9K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+9K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+9K201948AcroDTI VisualizerAcroviz, Inc.20200—
+9K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+9K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+9K200315Ziostation2Ziosoft, Inc.20200—
+9K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+9K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+9K183037Monaco RTP SystemElekta, Inc.201856
+9K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+9K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+9K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+9K142647mint LesionMint Medical GmbH201523
+10K260528OncoStudioOncosoft. Inc.,20260—
+10K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+10K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+10K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+10K250696AccuCheckManteia Technologies Co., Ltd.20250—
+10K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+10K250035Contour ProtégéAI+Mim Software, Inc.20251—
+10K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+10K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+10K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+10K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+10K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+10K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+10K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+10K220929ExcelsiorMerit Cro, Inc.20220—
+10K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+10K202229AI MetricsAi Metrics, LLC20200—
+10K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+10K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+10K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+10K200899Quantib AI NodeQuantib B.V.20200—
+10K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+10K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+10K190178Monaco RTP SystemElekta, Inc.201945
+10K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—