510(k) Report

Devices descending from K082427

229 later devices reach Syngo MR B17 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K173592MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM AvantofitSiemens Medical Solutions USA, Inc.20183Class I
+4K173600MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20177—
+4K172685LiverMultiScanPerspectum Diagnostics, Ltd.20177—
+4K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc.201730Class I
+4K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+4K163619Signa Pet/MRGe Medical Systems, LLC201717
+4K163211MAGNETOM Sempra with syngo MR E11SSiemens Medical Solutions USA, Inc.20177—
+4K163312MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 SoftwareSiemens Medical Solutions USA, Inc.20174—
+4K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+4K151353syngo.MR Neurology, syngo.MR OncologySiemens Medical Solutions USA, Inc.201525—
+4K140897Syngo.MR Neurology, Syngo.MMR GeneralSiemens Medical Solutions USA, Inc.20140—
+5K252571mdprostateMediaire GmbH20260—
+5K253690LungMapsSiemens Healthineers AG20260—
+5K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+5K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+5K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+5K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+5K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+5K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+5K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+5K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+5K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+5K220349TeraRecon NeuroTerarecon,Inc.20220—
+5K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+5K213709Signa Pet/MRGe Medical Systems, LLC202203
+5K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+5K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+5K201540uMR570Shanghai United Imaging Healthcare Co., Ltd.20205—
+5K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+5K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+5K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+5K193176uMR 780Shanghai United Imaging Healthcare Co., Ltd.20200—
+5K193200uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20208—
+5K192496Magnetom Sola, Magnetom Altea and Magnetom Sola FitSiemens Medical Solutions USA, Inc.20200—
+5K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20192—
+5K190017LiverMultiScan (LMSv3)Perspectum Diagnostics, Ltd.20196—
+5K190757MAGNETOM Avanto FitSiemens Medical Solution USA, Inc.20190—
+5K183221MAGNETOM Amira, MAGNETOM SempraSiemens Medical Solutions USA, Inc.201961
+5K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+5K182299MAGNETOM AeraSiemens Medical Solutions USA, Inc.20181—
+5K181433MAGNETOM VidaSiemens Medical Solutions USA, Inc.201828—
+5K173617MAGNETOM Vida with Compressed Sensing GRASP-VIBESiemens Medical Solutions USA, Inc.20180—
+5K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+5K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+6K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+6K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+6K241211CoLumboSmart Soft Healthcare20242—
+6K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+6K230758uMR 570Shanghai United Imaging Healthcare Co., Ltd.20230—
+6K223343MAGNETOM Amira; MAGNETOM SempraSiemens Medical Solutions USA, Inc.202301
+6K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+6K222755uMR 680Shanghai United Imaging Intelligence Co., Ltd.20233—
+6K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20221—
+6K220332uMR Omega with uWS-MR-MRSShanghai United Imaging Healthcare Co., Ltd.20227—
+6K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+6K220497CoLumboSmart Soft Healthcare AD20226—
+6K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+6K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+6K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+6K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+6K210611MAGNETOM Free.MaxSiemens Medical Solutions USA, Inc.202141
+6K202170LiverMultiScanPerspectum, Ltd.20203—
+6K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+6K200899Quantib AI NodeQuantib B.V.20200—
+6K190138MAGNETOM AeraSiemens Medical Solutions USA, Inc.20190—
+6K183244MAGNETOM LuminaSiemens Medical Solutions USA, Inc.20190Class I
+6K183254Magnetom VidaSiemens Medical Solutions USA, Inc.201926—
+7K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+7K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+7K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+7K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+7K250367CoLumboXSmart Soft Healthcare AD20250—
+7K243122uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20252—
+7K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+7K240793MSKaiMskai20240—
+7K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+7K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+7K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20240—
+7K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+7K240744uMR 680Shanghai United Imaging Healthcare Co., Ltd.20242—
+7K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+7K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+7K230152uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20236—
+7K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+7K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+7K213960LiverMultiScan v5 (LMSv5)Perspectum20221—
+7K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+7K220575MAGNETOM Free.Max, MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.202231
+7K203280Hepatica v1 (Hepatica v1.0.0)Perspectum, Ltd.20210—
+7K192924MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitSiemens Medical Solutions USA, Inc.202022Class I
+7K193324Motion Correction SystemKineticor, Inc.20202—
+8K253413LiverMultiScan (v6.0)Perspectum, Ltd.20260—
+8K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+8K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+8K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+8K243547uMR UltraShanghai United Imaging Healthcare Co., Ltd.20251—
+8K243397uMR 680Shanghai United Imaging Healthcare Co., Ltd.20251—
+8K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+8K233673uMR JupiterShanghai United Imaging Healthcare Co., Ltd.20241—
+8K240540uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20243—