510(k) Report

Devices descending from K951830

348 later devices reach Advantage Sim through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+7K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+7K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+8K253078ART.1-USSeetreat Pty, Ltd.20260—
+8K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+8K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+8K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202611
+8K252922Neosoma Brain MetsNeosoma, Inc.20250—
+8K251883MIM – LesionID ProMim Software, Inc.20250—
+8K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+8K252362GBrain MRIGalileo Cds, Inc.20250—
+8K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+8K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+8K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+8K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+8K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+8K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+8K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+8K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+8K241837Limbus ContourLimbus Ai, Inc.20240—
+8K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+8K233457RUSHutom, Inc.20240—
+8K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+8K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+8K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+8K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+8K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+8K231185MapRTVision Rt, Ltd.20231—
+8K230082Auto SegmentationGe Medical Systems, LLC20231—
+8K223774Contour ProtégéAIMim Software, Inc.20233—
+8K221706AccuContourManteia Technologies Co., Ltd.20232—
+8K220630TorchTM SoftwareVoximetry, Incorporated20221—
+8K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+8K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+8K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+8K203744Arterys MICAArterys, Inc.20221—
+8K213628VBrainVysioneer, Inc.20210—
+8K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+8K212116VBrain-OARVysioneer, Inc.20211—
+8K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+8K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+8K202789Monaco Rtp SystemElekta Solutions AB20213—
+8K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+8K203669Mobius3DVarian Medical Systems, Inc.20213—
+8K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+8K201948AcroDTI VisualizerAcroviz, Inc.20200—
+8K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+8K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+8K200315Ziostation2Ziosoft, Inc.20200—
+8K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+8K192455Merge PACSMerge Healthcare Incorporated201904
+8K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+8K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+8K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+8K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+8K142647mint LesionMint Medical GmbH201523
+9K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+9K253835AffinityHermes Medical Solutions AB20260—
+9K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation20260—
+9K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+9K260528OncoStudioOncosoft. Inc.,20260—
+9K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+9K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+9K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+9K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+9K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+9K252539Tempus PixelArterys, Inc.20250—
+9K243301MapRTVision Rt, Ltd.20250—
+9K250099Mobius3D (4.1)Varian Medical Systems20250—
+9K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+9K242925MR Contour DLGE Healthcare20250—
+9K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+9K231765Contour ProtégéAIMim Software, Inc.20232—
+9K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+9K223834AccuCheckManteia Technologies Co., Ltd.20231—
+9K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+9K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+9K220929ExcelsiorMerit Cro, Inc.20220—
+9K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+9K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+9K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+9K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+9K213787Monaco RTP SystemElekta Solutions AB20222—
+9K202229AI MetricsAi Metrics, LLC20200—
+9K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+9K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+9K200899Quantib AI NodeQuantib B.V.20200—
+9K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+9K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+9K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+9K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+10K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+10K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+10K252571mdprostateMediaire GmbH20260—
+10K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+10K253690LungMapsSiemens Healthineers AG20260—
+10K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+10K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+10K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+10K250696AccuCheckManteia Technologies Co., Ltd.20250—