510(k) Report

Devices descending from K121434

215 later devices reach Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+4K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+4K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+4K232322MAGNETOM Terra; MAGNETOM Terra.XSiemens Medical Solutions USA, Inc.20240—
+4K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+4K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+4K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+4K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+4K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+4K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+4K201540uMR570Shanghai United Imaging Healthcare Co., Ltd.20205—
+4K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+4K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+4K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+4K193176uMR 780Shanghai United Imaging Healthcare Co., Ltd.20200—
+4K193200uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20208—
+4K192496Magnetom Sola, Magnetom Altea and Magnetom Sola FitSiemens Medical Solutions USA, Inc.20200—
+4K190017LiverMultiScan (LMSv3)Perspectum Diagnostics, Ltd.20196—
+4K190757MAGNETOM Avanto FitSiemens Medical Solution USA, Inc.20190—
+4K183014uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20193—
+4K183221MAGNETOM Amira, MAGNETOM SempraSiemens Medical Solutions USA, Inc.201961
+4K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+4K182299MAGNETOM AeraSiemens Medical Solutions USA, Inc.20181—
+4K181433MAGNETOM VidaSiemens Medical Solutions USA, Inc.201828—
+4K173617MAGNETOM Vida with Compressed Sensing GRASP-VIBESiemens Medical Solutions USA, Inc.20180—
+4K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+4K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+4K163619Signa Pet/MRGe Medical Systems, LLC201717
+5K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+5K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+5K241211CoLumboSmart Soft Healthcare20242—
+5K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+5K230758uMR 570Shanghai United Imaging Healthcare Co., Ltd.20230—
+5K223343MAGNETOM Amira; MAGNETOM SempraSiemens Medical Solutions USA, Inc.202301
+5K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+5K222755uMR 680Shanghai United Imaging Intelligence Co., Ltd.20233—
+5K220332uMR Omega with uWS-MR-MRSShanghai United Imaging Healthcare Co., Ltd.20227—
+5K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+5K220497CoLumboSmart Soft Healthcare AD20226—
+5K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+5K213709Signa Pet/MRGe Medical Systems, LLC202203
+5K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+5K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+5K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+5K210611MAGNETOM Free.MaxSiemens Medical Solutions USA, Inc.202141
+5K202170LiverMultiScanPerspectum, Ltd.20203—
+5K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+5K200899Quantib AI NodeQuantib B.V.20200—
+5K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20192—
+5K190138MAGNETOM AeraSiemens Medical Solutions USA, Inc.20190—
+5K183244MAGNETOM LuminaSiemens Medical Solutions USA, Inc.20190Class I
+5K183254Magnetom VidaSiemens Medical Solutions USA, Inc.201926—
+6K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+6K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+6K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+6K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+6K250367CoLumboXSmart Soft Healthcare AD20250—
+6K243122uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20252—
+6K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+6K240793MSKaiMskai20240—
+6K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+6K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+6K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+6K240744uMR 680Shanghai United Imaging Healthcare Co., Ltd.20242—
+6K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+6K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+6K230152uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20236—
+6K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+6K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20221—
+6K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+6K213960LiverMultiScan v5 (LMSv5)Perspectum20221—
+6K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+6K220575MAGNETOM Free.Max, MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.202231
+6K203280Hepatica v1 (Hepatica v1.0.0)Perspectum, Ltd.20210—
+6K192924MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitSiemens Medical Solutions USA, Inc.202022Class I
+6K193324Motion Correction SystemKineticor, Inc.20202—
+7K253413LiverMultiScan (v6.0)Perspectum, Ltd.20260—
+7K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+7K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+7K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+7K243547uMR UltraShanghai United Imaging Healthcare Co., Ltd.20251—
+7K243397uMR 680Shanghai United Imaging Healthcare Co., Ltd.20251—
+7K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20240—
+7K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+7K233673uMR JupiterShanghai United Imaging Healthcare Co., Ltd.20241—
+7K240540uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20243—
+7K231617MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.20232—
+7K213805MAGNETOM VidaSiemens Medical Solutions USA, Inc.20230—
+7K220939MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50ASiemens Medical Solutions USA, Inc.20220Class I
+7K203451TCL3 Motion Tracking SystemTracinnovations Aps20211—
+7K203443MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM AlteaSiemens Medical Solutions USA, Inc.202120Class I
+7K202014Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fitSiemens Medical Solutions USA, Inc.20200Class I
+8K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+8K260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.20260—
+8K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+8K251822MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance, Ltd.20251—
+8K252371uMR 680Shanghai United Imaging Healthcare Co., Ltd.20250—
+8K250246uMR JupiterShanghai United Imaging Healthcare Co., Ltd.20250—
+8K241069iLoop Interventional Coil 0.55TNoras Mri Products GmbH20240—
+8K221785TCL3 Motion Tracking SystemTracinnovations A/S20220—