510(k) Report

Devices descending from K082427

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181892Ziostation2Ziosoft, Inc.20181—
+1K130885Magnetom Avanto-Fit, Magnetom Skyra-FitSiemens Medical Solutions USA, Inc.20130Class I
+1K123938Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree, Syngo MR B19 for…Siemens Medical Solutions USA, Inc.201338—
+1K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc.2012215Class I
+1K121160Magnetom SpectraSiemens Medical Solutions USA, Inc.20121Class I
+1K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+1K111242Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc.20112203
+1K103429Biograph MMRSiemens Medical Solutions USA, Inc.2011211
+1K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc.2010224Class I
+2K231133neo315Neoscan Solution GmbH20240—
+2K200315Ziostation2Ziosoft, Inc.20200—
+2K191050MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease…Siemens Medical Solutions USA, Inc.20190—
+2K181613MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11DSiemens Medical Solutions USA, Inc.20180Class I
+2K170840MAGNETOM TerraSiemens Medical Solutions USA, Inc.20172—
+2K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc.201712—
+2K153447MAGNETOM SpectraSiemens Medical Solutions USA, Inc.201601
+2K152602Olea Sphere V3.0Olea Medical201617—
+2K141977Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A…Siemens Medical Solutions USA, Inc.2014115—
+2K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+2K140253Magnetom Artis Combi Suite for the Magnetom Aera/Skyra/Skyra with Timtx TrueshapeSiemens Medical Solutions USA, Inc.20141—
+2K133435Magnetom Aera and Skyra with Software MR D13ASiemens Medical Solutions USA, Inc.20130—
+2K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc.201312Class I
+2K132951Magnetom AeraSiemens Medical Solutions USA, Inc.201391
+2K133226Biograph MMRSiemens Medical Solutions USA, Inc.2013201
+2K132831Quiet/Silent Scanning SuiteSiemens Medical Solutions USA, Inc.20130—
+2K130749Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc.201354—
+2K123510Magnetom SkyraSiemens Medical Solutions USA, Inc.201316—
+2K130262Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc.201311—
+2K123920Syngo.ViaSiemens AG Medical Solutions201363—
+2K121459Syngo.MR NeurologySiemens Medical Solutions USA, Inc.20123—
+2K120315Syngo.MR Spectro Engine, Syngo.MR Spectro SVS, Syngo.MR Spectro Csi, Syngo.MR Spectro…Siemens Medical Solutions USA, Inc.201223—
+3K253963Cubresa BrainPETCubresa, Inc.20260—
+3K243681Neuro Insight V1.0Olea Medical S.A.S.20250—
+3K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+3K230856BrainSpec Core™ SoftwareBrainspec, Inc.20230—
+3K223091CT Perfusion V1.0Olea Medical20230—
+3K223532Olea S.I.A. Neurovascular V1.0Olea Medical20231—
+3K230552MR DWI/FLAIR Measurement V1.0Olea Medical20230—
+3K211059CereFlow™ V1.2Translational Mri, LLC20231—
+3K223502MR Diffusion Perfusion Mismatch V1.0Olea Medical20230—
+3K212565CoverScan v1Perspectum, Ltd.20221—
+3K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+3K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L.20211—
+3K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+3K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.20201Class I
+3K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20191—
+3K183222MAGNETOM TerraSiemens Medical Solutions USA, Inc.20191—
+3K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+3K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+3K181370uMR 780Shanghai United Imaging Healthcare Co., Ltd.201811—
+3K181371uMR 790Shanghai United Imaging Healthcare Co., Ltd.201811—
+3K180926uMR 560Shanghai United Imaging Healthcare Co., Ltd.20180—
+3K180925uMR 570Shanghai United Imaging Healthcare Co., Ltd.20187—
+3K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+3K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+3K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+3K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+3K173467Advanced Diffusion Analysis (ADA) applicationPhilips Medical Systems Nederland B.V.20170—
+3K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.20170—
+3K170580Carestream Vue PACSCarestream Health, Inc.20171—
+3K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+3K161795Magnetom EssenzaSiemens Medical Solutions USA, Inc.20160—
+3K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc.201684Class I
+3K152283MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20159—
+3K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma…Siemens Medical Solutions USA, Inc.201585Class I
+3K143020LiverMultiScanMirada Medical, Ltd.20158—
+3K150069Fine Structure Analysis (fineSA)Acuitas Medical, Ltd.20150—
+3K150843syngo®.via (version VB10A)Siemens AG201546—
+3K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+3K142098Signa Pet/MRGe Medical Systems, LLC201466
+3K142515MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite…Siemens Medical Solutions USA, Inc.20140—
+3K133401Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR GeneralSiemens Medical Solutions USA, Inc.201427—
+3K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+4K253794Prostate CoreLucida Medical, Ltd.20260—
+4K253421Perfusion Measurement Platform v1Quantified Imaging Limited20260—
+4K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+4K253023BIOGRAPH OneSiemens Healthineers AG20260—
+4K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+4K243680Neurovascular Insight V1.0Olea Medical S.A.S.20250—
+4K232322MAGNETOM Terra; MAGNETOM Terra.XSiemens Medical Solutions USA, Inc.20240—
+4K230294CoverScan (CoverScan v1.1)Perspectum20230—
+4K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+4K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+4K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+4K201948AcroDTI VisualizerAcroviz, Inc.20200—
+4K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+4K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+4K200024uMR 570Shanghai United Imaging Healthcare Co., Ltd.20206—
+4K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+4K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+4K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+4K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+4K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+4K191157uMR 780, uMR 790Shanghai United Imaging Healthcare Co., Ltd.201910—
+4K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+4K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+4K183014uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20193—
+4K182129MAGNETOM SolaSiemens Medical Solutions USA, Inc.20181—
+4K181322MAGNETOM SolaSiemens Medical Solutions USA, Inc.20188—
+4K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—