510(k) Report

Devices descending from K100113

227 later devices reach Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223484IGAR System (1001.A)Insight Medbotics, Inc.20230—
+1K111242Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc.20112203
+1K112112Sentinelle Breast Mri Tabletop with 16 Channel Coil Array for Siemens 1.5/3T Mri SystemsSentinel Medical, Inc.20114—
+2K213735dS Sentinelle Breast 16ch 1.5T CoilInvivo Corporation (Business Trade Name: Philips)20222—
+2K213727dS Sentinelle Breast 16ch 3.0T CoilInvivo Corporation (Business Trade Name: Philips)20221—
+2K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc.2012215Class I
+2K121459Syngo.MR NeurologySiemens Medical Solutions USA, Inc.20123—
+3K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil…Philips Medical Systems Nederland B.V.20260—
+3K23334816 Breast CoilPhilips Medical System Nederlands B.V.20230—
+3K191050MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease…Siemens Medical Solutions USA, Inc.20190—
+3K181613MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11DSiemens Medical Solutions USA, Inc.20180Class I
+3K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc.201712—
+3K152602Olea Sphere V3.0Olea Medical201617—
+3K141977Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A…Siemens Medical Solutions USA, Inc.2014115—
+3K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+3K140253Magnetom Artis Combi Suite for the Magnetom Aera/Skyra/Skyra with Timtx TrueshapeSiemens Medical Solutions USA, Inc.20141—
+3K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+3K133435Magnetom Aera and Skyra with Software MR D13ASiemens Medical Solutions USA, Inc.20130—
+3K132951Magnetom AeraSiemens Medical Solutions USA, Inc.201391
+3K132831Quiet/Silent Scanning SuiteSiemens Medical Solutions USA, Inc.20130—
+3K130749Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc.201354—
+3K123510Magnetom SkyraSiemens Medical Solutions USA, Inc.201316—
+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—
+3K123920Syngo.ViaSiemens AG Medical Solutions201363—
+4K253963Cubresa BrainPETCubresa, Inc.20260—
+4K243681Neuro Insight V1.0Olea Medical S.A.S.20250—
+4K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+4K231133neo315Neoscan Solution GmbH20240—
+4K223091CT Perfusion V1.0Olea Medical20230—
+4K223532Olea S.I.A. Neurovascular V1.0Olea Medical20231—
+4K230552MR DWI/FLAIR Measurement V1.0Olea Medical20230—
+4K211059CereFlow™ V1.2Translational Mri, LLC20231—
+4K223502MR Diffusion Perfusion Mismatch V1.0Olea Medical20230—
+4K212565CoverScan v1Perspectum, Ltd.20221—
+4K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+4K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L.20211—
+4K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+4K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+4K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.20201Class I
+4K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20191—
+4K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+4K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+4K181370uMR 780Shanghai United Imaging Healthcare Co., Ltd.201811—
+4K180926uMR 560Shanghai United Imaging Healthcare Co., Ltd.20180—
+4K180925uMR 570Shanghai United Imaging Healthcare Co., Ltd.20187—
+4K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+4K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+4K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+4K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+4K173467Advanced Diffusion Analysis (ADA) applicationPhilips Medical Systems Nederland B.V.20170—
+4K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.20170—
+4K170840MAGNETOM TerraSiemens Medical Solutions USA, Inc.20172—
+4K170580Carestream Vue PACSCarestream Health, Inc.20171—
+4K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+4K161795Magnetom EssenzaSiemens Medical Solutions USA, Inc.20160—
+4K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc.201684Class I
+4K153447MAGNETOM SpectraSiemens Medical Solutions USA, Inc.201601
+4K152283MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20159—
+4K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma…Siemens Medical Solutions USA, Inc.201585Class I
+4K143020LiverMultiScanMirada Medical, Ltd.20158—
+4K150069Fine Structure Analysis (fineSA)Acuitas Medical, Ltd.20150—
+4K150843syngo®.via (version VB10A)Siemens AG201546—
+4K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+4K142515MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite…Siemens Medical Solutions USA, Inc.20140—
+4K133401Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR GeneralSiemens Medical Solutions USA, Inc.201427—
+4K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc.201312Class I
+4K133226Biograph MMRSiemens Medical Solutions USA, Inc.2013201
+5K253794Prostate CoreLucida Medical, Ltd.20260—
+5K253421Perfusion Measurement Platform v1Quantified Imaging Limited20260—
+5K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+5K253023BIOGRAPH OneSiemens Healthineers AG20260—
+5K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+5K243680Neurovascular Insight V1.0Olea Medical S.A.S.20250—
+5K230294CoverScan (CoverScan v1.1)Perspectum20230—
+5K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+5K220349TeraRecon NeuroTerarecon,Inc.20220—
+5K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+5K201948AcroDTI VisualizerAcroviz, Inc.20200—
+5K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+5K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+5K200024uMR 570Shanghai United Imaging Healthcare Co., Ltd.20206—
+5K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+5K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+5K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+5K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+5K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+5K191157uMR 780, uMR 790Shanghai United Imaging Healthcare Co., Ltd.201910—
+5K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+5K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+5K183222MAGNETOM TerraSiemens Medical Solutions USA, Inc.20191—
+5K182129MAGNETOM SolaSiemens Medical Solutions USA, Inc.20181—
+5K181322MAGNETOM SolaSiemens Medical Solutions USA, Inc.20188—
+5K181371uMR 790Shanghai United Imaging Healthcare Co., Ltd.201811—
+5K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+5K173592MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM AvantofitSiemens Medical Solutions USA, Inc.20183Class I
+5K173600MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20177—
+5K172685LiverMultiScanPerspectum Diagnostics, Ltd.20177—
+5K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc.201730Class I