510(k) Report

Devices descending from K083166

222 later devices reach Specialty Coils for the Magnetom Essenza through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130262Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc.201311—
+1K103275Specialty Coils for Magnetom Aera 1.5T & Magnetim Skyra 3T MR SystemsSiemens Medical Solutions USA, Inc.2011221—
+2K161795Magnetom EssenzaSiemens Medical Solutions USA, Inc.20160—
+2K152283MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20159—
+2K111242Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc.20112203
+3K173600MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20177—
+3K163211MAGNETOM Sempra with syngo MR E11SSiemens Medical Solutions USA, Inc.20177—
+3K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc.2012215Class I
+3K121459Syngo.MR NeurologySiemens Medical Solutions USA, Inc.20123—
+4K191050MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease…Siemens Medical Solutions USA, Inc.20190—
+4K183221MAGNETOM Amira, MAGNETOM SempraSiemens Medical Solutions USA, Inc.201961
+4K181613MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11DSiemens Medical Solutions USA, Inc.20180Class I
+4K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc.201712—
+4K152602Olea Sphere V3.0Olea Medical201617—
+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—
+4K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+4K133435Magnetom Aera and Skyra with Software MR D13ASiemens Medical Solutions USA, Inc.20130—
+4K132951Magnetom AeraSiemens Medical Solutions USA, Inc.201391
+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—
+4K130885Magnetom Avanto-Fit, Magnetom Skyra-FitSiemens Medical Solutions USA, Inc.20130Class I
+4K123938Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree, Syngo MR B19 for…Siemens Medical Solutions USA, Inc.201338—
+4K123920Syngo.ViaSiemens AG Medical Solutions201363—
+5K253963Cubresa BrainPETCubresa, Inc.20260—
+5K243681Neuro Insight V1.0Olea Medical S.A.S.20250—
+5K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+5K231133neo315Neoscan Solution GmbH20240—
+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—
+5K223343MAGNETOM Amira; MAGNETOM SempraSiemens Medical Solutions USA, Inc.202301
+5K223502MR Diffusion Perfusion Mismatch V1.0Olea Medical20230—
+5K212565CoverScan v1Perspectum, Ltd.20221—
+5K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+5K210611MAGNETOM Free.MaxSiemens Medical Solutions USA, Inc.202141
+5K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L.20211—
+5K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+5K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+5K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.20201Class I
+5K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.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—
+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—
+5K173467Advanced Diffusion Analysis (ADA) applicationPhilips Medical Systems Nederland B.V.20170—
+5K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.20170—
+5K170840MAGNETOM TerraSiemens Medical Solutions USA, Inc.20172—
+5K170580Carestream Vue PACSCarestream Health, Inc.20171—
+5K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+5K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc.201684Class I
+5K153447MAGNETOM SpectraSiemens Medical Solutions USA, Inc.201601
+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—
+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—
+5K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc.201312Class I
+5K133226Biograph MMRSiemens Medical Solutions USA, Inc.2013201
+6K253794Prostate CoreLucida Medical, Ltd.20260—
+6K253421Perfusion Measurement Platform v1Quantified Imaging Limited20260—
+6K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+6K253023BIOGRAPH OneSiemens Healthineers AG20260—
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K243680Neurovascular Insight V1.0Olea Medical S.A.S.20250—
+6K230294CoverScan (CoverScan v1.1)Perspectum20230—
+6K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+6K220349TeraRecon NeuroTerarecon,Inc.20220—
+6K220575MAGNETOM Free.Max, MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.202231
+6K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+6K201948AcroDTI VisualizerAcroviz, Inc.20200—
+6K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+6K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+6K200024uMR 570Shanghai United Imaging Healthcare Co., Ltd.20206—
+6K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+6K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+6K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+6K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+6K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+6K191157uMR 780, uMR 790Shanghai United Imaging Healthcare Co., Ltd.201910—
+6K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+6K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+6K183222MAGNETOM TerraSiemens Medical Solutions USA, Inc.20191—
+6K182129MAGNETOM SolaSiemens Medical Solutions USA, Inc.20181—
+6K181322MAGNETOM SolaSiemens Medical Solutions USA, Inc.20188—
+6K181371uMR 790Shanghai United Imaging Healthcare Co., Ltd.201811—
+6K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+6K173592MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM AvantofitSiemens Medical Solutions USA, Inc.20183Class I
+6K172685LiverMultiScanPerspectum Diagnostics, Ltd.20177—
+6K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc.201730Class I