510(k) Report

Devices descending from K141977

115 later devices reach Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161795Magnetom EssenzaSiemens Medical Solutions USA, Inc.20160—
+1K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc.201684Class I
+1K153447MAGNETOM SpectraSiemens Medical Solutions USA, Inc.201601
+1K152602Olea Sphere V3.0Olea Medical201617—
+1K152283MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20159—
+1K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma…Siemens Medical Solutions USA, Inc.201585Class I
+1K143020LiverMultiScanMirada Medical, Ltd.20158—
+2K243681Neuro Insight V1.0Olea Medical S.A.S.20250—
+2K223091CT Perfusion V1.0Olea Medical20230—
+2K223532Olea S.I.A. Neurovascular V1.0Olea Medical20231—
+2K230552MR DWI/FLAIR Measurement V1.0Olea Medical20230—
+2K211059CereFlow™ V1.2Translational Mri, LLC20231—
+2K223502MR Diffusion Perfusion Mismatch V1.0Olea Medical20230—
+2K212565CoverScan v1Perspectum, Ltd.20221—
+2K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L.20211—
+2K191050MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease…Siemens Medical Solutions USA, Inc.20190—
+2K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20191—
+2K182129MAGNETOM SolaSiemens Medical Solutions USA, Inc.20181—
+2K181322MAGNETOM SolaSiemens Medical Solutions USA, Inc.20188—
+2K173592MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM AvantofitSiemens Medical Solutions USA, Inc.20183Class I
+2K173600MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20177—
+2K173467Advanced Diffusion Analysis (ADA) applicationPhilips Medical Systems Nederland B.V.20170—
+2K172685LiverMultiScanPerspectum Diagnostics, Ltd.20177—
+2K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc.201730Class I
+2K170580Carestream Vue PACSCarestream Health, Inc.20171—
+2K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc.201712—
+2K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+2K163211MAGNETOM Sempra with syngo MR E11SSiemens Medical Solutions USA, Inc.20177—
+2K163312MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 SoftwareSiemens Medical Solutions USA, Inc.20174—
+3K253794Prostate CoreLucida Medical, Ltd.20260—
+3K253963Cubresa BrainPETCubresa, Inc.20260—
+3K253421Perfusion Measurement Platform v1Quantified Imaging Limited20260—
+3K243680Neurovascular Insight V1.0Olea Medical S.A.S.20250—
+3K230294CoverScan (CoverScan v1.1)Perspectum20230—
+3K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+3K201948AcroDTI VisualizerAcroviz, Inc.20200—
+3K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.20201Class I
+3K192496Magnetom Sola, Magnetom Altea and Magnetom Sola FitSiemens Medical Solutions USA, Inc.20200—
+3K190017LiverMultiScan (LMSv3)Perspectum Diagnostics, Ltd.20196—
+3K190757MAGNETOM Avanto FitSiemens Medical Solution USA, Inc.20190—
+3K183221MAGNETOM Amira, MAGNETOM SempraSiemens Medical Solutions USA, Inc.201961
+3K182299MAGNETOM AeraSiemens Medical Solutions USA, Inc.20181—
+3K181433MAGNETOM VidaSiemens Medical Solutions USA, Inc.201828—
+3K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+3K173617MAGNETOM Vida with Compressed Sensing GRASP-VIBESiemens Medical Solutions USA, Inc.20180—
+3K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+3K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.20170—
+4K253023BIOGRAPH OneSiemens Healthineers AG20260—
+4K223343MAGNETOM Amira; MAGNETOM SempraSiemens Medical Solutions USA, Inc.202301
+4K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+4K210611MAGNETOM Free.MaxSiemens Medical Solutions USA, Inc.202141
+4K202170LiverMultiScanPerspectum, Ltd.20203—
+4K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+4K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+4K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+4K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+4K190138MAGNETOM AeraSiemens Medical Solutions USA, Inc.20190—
+4K183244MAGNETOM LuminaSiemens Medical Solutions USA, Inc.20190Class I
+4K183254Magnetom VidaSiemens Medical Solutions USA, Inc.201926—
+5K252571mdprostateMediaire GmbH20260—
+5K253690LungMapsSiemens Healthineers AG20260—
+5K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+5K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+5K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+5K213960LiverMultiScan v5 (LMSv5)Perspectum20221—
+5K220575MAGNETOM Free.Max, MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.202231
+5K203280Hepatica v1 (Hepatica v1.0.0)Perspectum, Ltd.20210—
+5K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+5K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+5K192924MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitSiemens Medical Solutions USA, Inc.202022Class I
+5K193324Motion Correction SystemKineticor, Inc.20202—
+6K253413LiverMultiScan (v6.0)Perspectum, Ltd.20260—
+6K241211CoLumboSmart Soft Healthcare20242—
+6K231617MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.20232—
+6K213805MAGNETOM VidaSiemens Medical Solutions USA, Inc.20230—
+6K220497CoLumboSmart Soft Healthcare AD20226—
+6K220939MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50ASiemens Medical Solutions USA, Inc.20220Class I
+6K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+6K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+6K203451TCL3 Motion Tracking SystemTracinnovations Aps20211—
+6K203443MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM AlteaSiemens Medical Solutions USA, Inc.202120Class I
+6K202014Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fitSiemens Medical Solutions USA, Inc.20200Class I
+7K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+7K251822MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance, Ltd.20251—
+7K250367CoLumboXSmart Soft Healthcare AD20250—
+7K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+7K240793MSKaiMskai20240—
+7K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+7K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+7K241069iLoop Interventional Coil 0.55TNoras Mri Products GmbH20240—
+7K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+7K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+7K221785TCL3 Motion Tracking SystemTracinnovations A/S20220—
+7K220589MAGNETOM Skyra FitSiemens Medical Solutions USA, Inc.20223Class I
+7K220151MAGNETOM Avanto FitSiemens Medical Solutions USA, Inc.20223—
+7K220425MAGNETOM Vida, MAGNETOM SolaSiemens Medical Solutions USA, Inc.20220—
+7K213693MAGNETOM Vida with syngo MR XA50ASiemens Medical Solutions USA, Inc.202213—
+8K260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance, Ltd.20260—
+8K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+8K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I