510(k) Report

Devices descending from K121434

215 later devices reach Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio 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—
+1K181613MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11DSiemens Medical Solutions USA, Inc.20180Class I
+1K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc.201712—
+1K152602Olea Sphere V3.0Olea Medical201617—
+1K141977Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A…Siemens Medical Solutions USA, Inc.2014115—
+1K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+1K140253Magnetom Artis Combi Suite for the Magnetom Aera/Skyra/Skyra with Timtx TrueshapeSiemens Medical Solutions USA, Inc.20141—
+1K133435Magnetom Aera and Skyra with Software MR D13ASiemens Medical Solutions USA, Inc.20130—
+1K132951Magnetom AeraSiemens Medical Solutions USA, Inc.201391
+1K132831Quiet/Silent Scanning SuiteSiemens Medical Solutions USA, Inc.20130—
+1K130749Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc.201354—
+1K123510Magnetom SkyraSiemens Medical Solutions USA, Inc.201316—
+1K130885Magnetom Avanto-Fit, Magnetom Skyra-FitSiemens Medical Solutions USA, Inc.20130Class I
+1K130262Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc.201311—
+1K123938Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree, Syngo MR B19 for…Siemens Medical Solutions USA, Inc.201338—
+1K123920Syngo.ViaSiemens AG Medical Solutions201363—
+2K253963Cubresa BrainPETCubresa, Inc.20260—
+2K243681Neuro Insight V1.0Olea Medical S.A.S.20250—
+2K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+2K231133neo315Neoscan Solution GmbH20240—
+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—
+2K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+2K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L.20211—
+2K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+2K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.20201Class I
+2K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20191—
+2K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+2K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+2K181370uMR 780Shanghai United Imaging Healthcare Co., Ltd.201811—
+2K180926uMR 560Shanghai United Imaging Healthcare Co., Ltd.20180—
+2K180925uMR 570Shanghai United Imaging Healthcare Co., Ltd.20187—
+2K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+2K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+2K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+2K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+2K173467Advanced Diffusion Analysis (ADA) applicationPhilips Medical Systems Nederland B.V.20170—
+2K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.20170—
+2K170840MAGNETOM TerraSiemens Medical Solutions USA, Inc.20172—
+2K170580Carestream Vue PACSCarestream Health, Inc.20171—
+2K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+2K161795Magnetom EssenzaSiemens Medical Solutions USA, Inc.20160—
+2K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc.201684Class I
+2K153447MAGNETOM SpectraSiemens Medical Solutions USA, Inc.201601
+2K152283MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20159—
+2K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma…Siemens Medical Solutions USA, Inc.201585Class I
+2K143020LiverMultiScanMirada Medical, Ltd.20158—
+2K150069Fine Structure Analysis (fineSA)Acuitas Medical, Ltd.20150—
+2K150843syngo®.via (version VB10A)Siemens AG201546—
+2K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+2K142515MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite…Siemens Medical Solutions USA, Inc.20140—
+2K133401Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR GeneralSiemens Medical Solutions USA, Inc.201427—
+2K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc.201312Class I
+2K133226Biograph MMRSiemens Medical Solutions USA, Inc.2013201
+3K253794Prostate CoreLucida Medical, Ltd.20260—
+3K253421Perfusion Measurement Platform v1Quantified Imaging Limited20260—
+3K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+3K253023BIOGRAPH OneSiemens Healthineers AG20260—
+3K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+3K243680Neurovascular Insight V1.0Olea Medical S.A.S.20250—
+3K230294CoverScan (CoverScan v1.1)Perspectum20230—
+3K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+3K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+3K201948AcroDTI VisualizerAcroviz, Inc.20200—
+3K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+3K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+3K200024uMR 570Shanghai United Imaging Healthcare Co., Ltd.20206—
+3K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+3K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+3K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+3K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+3K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+3K191157uMR 780, uMR 790Shanghai United Imaging Healthcare Co., Ltd.201910—
+3K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+3K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+3K183222MAGNETOM TerraSiemens Medical Solutions USA, Inc.20191—
+3K182129MAGNETOM SolaSiemens Medical Solutions USA, Inc.20181—
+3K181322MAGNETOM SolaSiemens Medical Solutions USA, Inc.20188—
+3K181371uMR 790Shanghai United Imaging Healthcare Co., Ltd.201811—
+3K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+3K173592MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM AvantofitSiemens Medical Solutions USA, Inc.20183Class I
+3K173600MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20177—
+3K172685LiverMultiScanPerspectum Diagnostics, Ltd.20177—
+3K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc.201730Class I
+3K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+3K163211MAGNETOM Sempra with syngo MR E11SSiemens Medical Solutions USA, Inc.20177—
+3K163312MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 SoftwareSiemens Medical Solutions USA, Inc.20174—
+3K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+3K151353syngo.MR Neurology, syngo.MR OncologySiemens Medical Solutions USA, Inc.201525—
+3K142098Signa Pet/MRGe Medical Systems, LLC201466
+3K140897Syngo.MR Neurology, Syngo.MMR GeneralSiemens Medical Solutions USA, Inc.20140—
+4K252571mdprostateMediaire GmbH20260—
+4K253690LungMapsSiemens Healthineers AG20260—
+4K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+4K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+4K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I