510(k) Report

Devices descending from K052164

312 later devices reach Magnetom Systems with Software Syngo MR 2006A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080048MSK Extreme MR Scanner, Model AA5000Oni Medical Systems, Inc.200823
+1K062454Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc.2006308—
+2K1032381.5T Optima MR430SGe Medical Systems, LLC201112
+2K082427Syngo MR B17Siemens Medical Solutions USA, Inc.2008229—
+2K072237Magnetom VerioSiemens Medical Solutions USA, Inc.2007300Class I
+2K071925Magnetom EssenzaSiemens Medical Solutions USA, Inc.20072281
+3K181892Ziostation2Ziosoft, Inc.20181—
+3K130885Magnetom Avanto-Fit, Magnetom Skyra-FitSiemens Medical Solutions USA, Inc.20130Class I
+3K130262Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc.201311—
+3K123938Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree, Syngo MR B19 for…Siemens Medical Solutions USA, Inc.201338—
+3K123068Optima MR 430SGe Medical Systems, LLC201202
+3K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc.2012215Class I
+3K121160Magnetom SpectraSiemens Medical Solutions USA, Inc.20121Class I
+3K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+3K111242Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc.20112203
+3K103429Biograph MMRSiemens Medical Solutions USA, Inc.2011211
+3K103275Specialty Coils for Magnetom Aera 1.5T & Magnetim Skyra 3T MR SystemsSiemens Medical Solutions USA, Inc.2011221—
+3K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc.2010224Class I
+3K0929253D ASLGe Medical Systems, LLC20100—
+3K092237NSM-S15 SystemNeusoft Medical Systems Co., Ltd.20090—
+3K083166Specialty Coils for the Magnetom EssenzaSiemens Medical Solutions USA, Inc.2009222—
+3K082331Magnetom C!Siemens Medical Solutions USA, Inc.20083—
+3K081028Signa 3.0T MR750 SystemGe Medical Systems, LLC20087011
+4K231133neo315Neoscan Solution GmbH20240—
+4K200315Ziostation2Ziosoft, Inc.20200—
+4K191050MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease…Siemens Medical Solutions USA, Inc.20190—
+4K190524MRopen 0.5 TAsg Superconductors S.P.A.20192—
+4K181613MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11DSiemens Medical Solutions USA, Inc.20180Class I
+4K170840MAGNETOM TerraSiemens Medical Solutions USA, Inc.20172—
+4K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc.201712—
+4K161795Magnetom EssenzaSiemens Medical Solutions USA, Inc.20160—
+4K153447MAGNETOM SpectraSiemens Medical Solutions USA, Inc.201601
+4K152602Olea Sphere V3.0Olea Medical201617—
+4K152283MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20159—
+4K141977Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A…Siemens Medical Solutions USA, Inc.2014115—
+4K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+4K140253Magnetom Artis Combi Suite for the Magnetom Aera/Skyra/Skyra with Timtx TrueshapeSiemens Medical Solutions USA, Inc.20141—
+4K133435Magnetom Aera and Skyra with Software MR D13ASiemens Medical Solutions USA, Inc.20130—
+4K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc.201312Class I
+4K132951Magnetom AeraSiemens Medical Solutions USA, Inc.201391
+4K133226Biograph MMRSiemens Medical Solutions USA, Inc.2013201
+4K132831Quiet/Silent Scanning SuiteSiemens Medical Solutions USA, Inc.20130—
+4K130749Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc.201354—
+4K123510Magnetom SkyraSiemens Medical Solutions USA, Inc.201316—
+4K123920Syngo.ViaSiemens AG Medical Solutions201363—
+4K121459Syngo.MR NeurologySiemens Medical Solutions USA, Inc.20123—
+4K120315Syngo.MR Spectro Engine, Syngo.MR Spectro SVS, Syngo.MR Spectro Csi, Syngo.MR Spectro…Siemens Medical Solutions USA, Inc.201223—
+4K103327Discovery MR750W 3.0TGe Healthcare Japan Corporation2011526
+4K083147Discovery MR450Ge Medical Systems, LLC20086910
+5K253963Cubresa BrainPETCubresa, Inc.20260—
+5K243681Neuro Insight V1.0Olea Medical S.A.S.20250—
+5K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+5K230856BrainSpec Core™ SoftwareBrainspec, Inc.20230—
+5K223091CT Perfusion V1.0Olea Medical20230—
+5K223532Olea S.I.A. Neurovascular V1.0Olea Medical20231—
+5K230552MR DWI/FLAIR Measurement V1.0Olea Medical20230—
+5K211059CereFlow™ V1.2Translational Mri, LLC20231—
+5K223502MR Diffusion Perfusion Mismatch V1.0Olea Medical20230—
+5K212565CoverScan v1Perspectum, Ltd.20221—
+5K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+5K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L.20211—
+5K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+5K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.20201Class I
+5K193116MRopen EVOAsg Superconductors S.P.A.20191—
+5K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20191—
+5K183222MAGNETOM TerraSiemens Medical Solutions USA, Inc.20191—
+5K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+5K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+5K181370uMR 780Shanghai United Imaging Healthcare Co., Ltd.201811—
+5K181371uMR 790Shanghai United Imaging Healthcare Co., Ltd.201811—
+5K180926uMR 560Shanghai United Imaging Healthcare Co., Ltd.20180—
+5K180925uMR 570Shanghai United Imaging Healthcare Co., Ltd.20187—
+5K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+5K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+5K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+5K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+5K173600MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20177—
+5K173467Advanced Diffusion Analysis (ADA) applicationPhilips Medical Systems Nederland B.V.20170—
+5K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.20170—
+5K170580Carestream Vue PACSCarestream Health, Inc.20171—
+5K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+5K163211MAGNETOM Sempra with syngo MR E11SSiemens Medical Solutions USA, Inc.20177—
+5K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc.201684Class I
+5K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma…Siemens Medical Solutions USA, Inc.201585Class I
+5K143020LiverMultiScanMirada Medical, Ltd.20158—
+5K150069Fine Structure Analysis (fineSA)Acuitas Medical, Ltd.20150—
+5K150843syngo®.via (version VB10A)Siemens AG201546—
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K142098Signa Pet/MRGe Medical Systems, LLC201466
+5K142515MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite…Siemens Medical Solutions USA, Inc.20140—
+5K133401Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR GeneralSiemens Medical Solutions USA, Inc.201427—
+5K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+5K131241SWIPPhilips Medical Systems Nederland B.V.20135—
+5K130115Discovery MR750W 3.0TGe Medical Systems, LLC2013431
+5K123417Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd.201356
+5K1216761.5T Signa HDXT 3.0T Signa HDXT Signa VibrantGe Medical Systems, LLC2012510
+5K103330Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd.201176
+5K091536Optima MR450WGe Medical Systems, LLC2009598
+6K253794Prostate CoreLucida Medical, Ltd.20260—
+6K253421Perfusion Measurement Platform v1Quantified Imaging Limited20260—