510(k) Report

Devices descending from K013531

307 later devices reach Qwiksim Virtual Simulation System; Version 2.00 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+8K252362GBrain MRIGalileo Cds, Inc.20250—
+8K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+8K243301MapRTVision Rt, Ltd.20250—
+8K250099Mobius3D (4.1)Varian Medical Systems20250—
+8K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+8K242925MR Contour DLGE Healthcare20250—
+8K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+8K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+8K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+8K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+8K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+8K231765Contour ProtégéAIMim Software, Inc.20232—
+8K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+8K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+8K223834AccuCheckManteia Technologies Co., Ltd.20231—
+8K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+8K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+8K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+8K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+8K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+8K213787Monaco RTP SystemElekta Solutions AB20222—
+8K203744Arterys MICAArterys, Inc.20221—
+8K201948AcroDTI VisualizerAcroviz, Inc.20200—
+8K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+8K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+8K200315Ziostation2Ziosoft, Inc.20200—
+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
+9K260528OncoStudioOncosoft. Inc.,20260—
+9K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+9K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+9K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+9K250696AccuCheckManteia Technologies Co., Ltd.20250—
+9K252539Tempus PixelArterys, Inc.20250—
+9K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+9K250035Contour ProtégéAI+Mim Software, Inc.20251—
+9K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+9K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+9K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+9K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+9K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+9K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+9K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+9K223233Monaco RTP SystemElekta Solutions AB20231—
+9K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+9K220929ExcelsiorMerit Cro, Inc.20220—
+9K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+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—
+10K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+10K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+10K253270Contour ProtégéAI+Mim Software, Inc.20260—
+10K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+10K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+10K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+10K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+10K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+10K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+10K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+10K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+10K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+10K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+10K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+10K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+10K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+11K261306AI Contouring (VA10A)Varian Medical Systems20260—
+11K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+11K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+11K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+11K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+11K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+11K241211CoLumboSmart Soft Healthcare20242—
+11K220497CoLumboSmart Soft Healthcare AD20226—
+11K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+11K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+12K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+12K250367CoLumboXSmart Soft Healthcare AD20250—
+12K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+12K240793MSKaiMskai20240—
+12K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+12K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+12K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+13K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+13K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+13K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—