510(k) Report

Devices descending from K153343

84 later devices reach MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191050MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease…Siemens Medical Solutions USA, Inc.20190—
+1K182129MAGNETOM SolaSiemens Medical Solutions USA, Inc.20181—
+1K181322MAGNETOM SolaSiemens Medical Solutions USA, Inc.20188—
+1K173592MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM AvantofitSiemens Medical Solutions USA, Inc.20183Class I
+1K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc.201730Class I
+1K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc.201712—
+1K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+1K163312MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 SoftwareSiemens Medical Solutions USA, Inc.20174—
+2K253963Cubresa BrainPETCubresa, Inc.20260—
+2K201948AcroDTI VisualizerAcroviz, Inc.20200—
+2K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.20201Class I
+2K192496Magnetom Sola, Magnetom Altea and Magnetom Sola FitSiemens Medical Solutions USA, Inc.20200—
+2K190757MAGNETOM Avanto FitSiemens Medical Solution USA, Inc.20190—
+2K183221MAGNETOM Amira, MAGNETOM SempraSiemens Medical Solutions USA, Inc.201961
+2K182299MAGNETOM AeraSiemens Medical Solutions USA, Inc.20181—
+2K181433MAGNETOM VidaSiemens Medical Solutions USA, Inc.201828—
+2K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+2K173617MAGNETOM Vida with Compressed Sensing GRASP-VIBESiemens Medical Solutions USA, Inc.20180—
+2K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+2K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.20170—
+3K253023BIOGRAPH OneSiemens Healthineers AG20260—
+3K223343MAGNETOM Amira; MAGNETOM SempraSiemens Medical Solutions USA, Inc.202301
+3K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+3K210611MAGNETOM Free.MaxSiemens Medical Solutions USA, Inc.202141
+3K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+3K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+3K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+3K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+3K190138MAGNETOM AeraSiemens Medical Solutions USA, Inc.20190—
+3K183244MAGNETOM LuminaSiemens Medical Solutions USA, Inc.20190Class I
+3K183254Magnetom VidaSiemens Medical Solutions USA, Inc.201926—
+4K252571mdprostateMediaire GmbH20260—
+4K253690LungMapsSiemens Healthineers AG20260—
+4K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+4K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+4K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+4K220575MAGNETOM Free.Max, MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.202231
+4K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+4K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+4K192924MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitSiemens Medical Solutions USA, Inc.202022Class I
+4K193324Motion Correction SystemKineticor, Inc.20202—
+5K241211CoLumboSmart Soft Healthcare20242—
+5K231617MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.20232—
+5K213805MAGNETOM VidaSiemens Medical Solutions USA, Inc.20230—
+5K220497CoLumboSmart Soft Healthcare AD20226—
+5K220939MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50ASiemens Medical Solutions USA, Inc.20220Class I
+5K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+5K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+5K203451TCL3 Motion Tracking SystemTracinnovations Aps20211—
+5K203443MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM AlteaSiemens Medical Solutions USA, Inc.202120Class I
+5K202014Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fitSiemens Medical Solutions USA, Inc.20200Class I
+6K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+6K251822MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance, Ltd.20251—
+6K250367CoLumboXSmart Soft Healthcare AD20250—
+6K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+6K240793MSKaiMskai20240—
+6K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+6K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+6K241069iLoop Interventional Coil 0.55TNoras Mri Products GmbH20240—
+6K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+6K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+6K221785TCL3 Motion Tracking SystemTracinnovations A/S20220—
+6K220589MAGNETOM Skyra FitSiemens Medical Solutions USA, Inc.20223Class I
+6K220151MAGNETOM Avanto FitSiemens Medical Solutions USA, Inc.20223—
+6K220425MAGNETOM Vida, MAGNETOM SolaSiemens Medical Solutions USA, Inc.20220—
+6K213693MAGNETOM Vida with syngo MR XA50ASiemens Medical Solutions USA, Inc.202213—
+7K260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance, Ltd.20260—
+7K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+7K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+7K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+7K232765MAGNETOM Cima.X FitSiemens Medical Solutions USA, Inc.20240—
+7K231587MAGNETOM Cima.XSiemens Medical Solutions USA, Inc.20230Class I
+7K232494MAGNETOM Avanto fit; MAGNETOM Skyra fitSiemens Medical Solutions USA, Inc.20230Class I
+7K231560MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM…Siemens Medical Solutions USA, Inc.20232Class I
+7K221733MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola FitSiemens Medical Solutions USA, Inc.20229—
+8K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+8K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+8K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+8K232535MAGNETOM Sola; MAGNETOM AlteaSiemens Medical Solutions USA, Inc.20234—
+8K232482MAGNETOM Viato.MobileSiemens Medical Solutions USA, Inc.20234—
+9K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+9K250436MAGNETOM Flow.Ace; MAGNETOM Flow.PlusSiemens Shenzhen Magnetic Resonance, Ltd.20251—
+9K240608MAGNETOM Viato.MobileSiemens Medical Solutions USA, Inc.20243—
+10K260265MAGNETOM Flow.Ace; MAGNETOM Flow.PlusSiemens Shenzhen Magnetic Resonance, Ltd.20260—