510(k) Report

Devices descending from K001210

242 later devices reach HI-Res 9000 Phased Array Carotid Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023982Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist CoilUsa Instruments, Inc.200322—
+1K013528Crystal 5000 Phases Array TMJ CoilUsa Instruments, Inc.20010—
+1K012491Machnet Carotids Coil Array AssemblyMachnet BV2001229—
+2K092962Carotid Coil 5000004901Shanghai Chenguang Medical Technologies Co, Ltd.20092—
+2K083578Noras CPC Multifunctional CoilNoras Mri Products GmbH20091—
+2K083166Specialty Coils for the Magnetom EssenzaSiemens Medical Solutions USA, Inc.2009222—
+2K082636TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TQuality Electrodynamics2008218
+2K070778Neocoil 3.0T 6-Channel Carotid Array CoilNeocoil20070—
+3K162966TxRx Knee 15 Flare MR Coil 1.5TQuality Electrodynamics, LLC20160—
+3K163066TxRx Knee 15 Flare MR Coil 3.0TQuality Electrodynamics, LLC20160—
+3K15033118ch T/R Knee CoilQuality Electrodynamics, LLC20155—
+3K14025216 CH Multipurpose Coil VarietyNoras Rontgen-Und Medizintechnik GmbH20140—
+3K130262Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc.201311—
+3K112002Carotid CoilShanghai Chenguang Medical Technologies Co, Ltd.20111—
+3K103275Specialty Coils for Magnetom Aera 1.5T & Magnetim Skyra 3T MR SystemsSiemens Medical Solutions USA, Inc.2011221—
+3K10014114-Channel Extremity Coil for Magnetom EssenzaSiemens Medical Solutions USA, Inc.201012—
+4K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd.20190—
+4K16262316ch T/R Hand Wrist CoilQuality Electrodynamics, LLC20161—
+4K161795Magnetom EssenzaSiemens Medical Solutions USA, Inc.20160—
+4K16202916ch T/R Knee CoilQuality Electrodynamics, LLC20160—
+4K152283MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20159—
+4K15175316 ch Tx/Rx Knee SPEEDERQuality Electrodynamics, LLC20151—
+4K111242Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc.20112203
+5K17346916ch T/R Hand Wrist CoilQuality Electrodynamics, LLC20180—
+5K173600MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20177—
+5K163211MAGNETOM Sempra with syngo MR E11SSiemens Medical Solutions USA, Inc.20177—
+5K16119316ch Tx/Rx Knee SPEEDERQuality Electrodynamics, LLC20160—
+5K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc.2012215Class I
+5K121459Syngo.MR NeurologySiemens Medical Solutions USA, Inc.20123—
+6K191050MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease…Siemens Medical Solutions USA, Inc.20190—
+6K183221MAGNETOM Amira, MAGNETOM SempraSiemens Medical Solutions USA, Inc.201961
+6K181613MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11DSiemens Medical Solutions USA, Inc.20180Class I
+6K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc.201712—
+6K152602Olea Sphere V3.0Olea Medical201617—
+6K141977Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A…Siemens Medical Solutions USA, Inc.2014115—
+6K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+6K140253Magnetom Artis Combi Suite for the Magnetom Aera/Skyra/Skyra with Timtx TrueshapeSiemens Medical Solutions USA, Inc.20141—
+6K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+6K133435Magnetom Aera and Skyra with Software MR D13ASiemens Medical Solutions USA, Inc.20130—
+6K132951Magnetom AeraSiemens Medical Solutions USA, Inc.201391
+6K132831Quiet/Silent Scanning SuiteSiemens Medical Solutions USA, Inc.20130—
+6K130749Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc.201354—
+6K123510Magnetom SkyraSiemens Medical Solutions USA, Inc.201316—
+6K130885Magnetom Avanto-Fit, Magnetom Skyra-FitSiemens Medical Solutions USA, Inc.20130Class I
+6K123938Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree, Syngo MR B19 for…Siemens Medical Solutions USA, Inc.201338—
+6K123920Syngo.ViaSiemens AG Medical Solutions201363—
+7K253963Cubresa BrainPETCubresa, Inc.20260—
+7K243681Neuro Insight V1.0Olea Medical S.A.S.20250—
+7K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+7K231133neo315Neoscan Solution GmbH20240—
+7K223091CT Perfusion V1.0Olea Medical20230—
+7K223532Olea S.I.A. Neurovascular V1.0Olea Medical20231—
+7K230552MR DWI/FLAIR Measurement V1.0Olea Medical20230—
+7K211059CereFlow™ V1.2Translational Mri, LLC20231—
+7K223343MAGNETOM Amira; MAGNETOM SempraSiemens Medical Solutions USA, Inc.202301
+7K223502MR Diffusion Perfusion Mismatch V1.0Olea Medical20230—
+7K212565CoverScan v1Perspectum, Ltd.20221—
+7K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+7K210611MAGNETOM Free.MaxSiemens Medical Solutions USA, Inc.202141
+7K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L.20211—
+7K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+7K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+7K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.20201Class I
+7K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20191—
+7K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+7K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+7K181370uMR 780Shanghai United Imaging Healthcare Co., Ltd.201811—
+7K180926uMR 560Shanghai United Imaging Healthcare Co., Ltd.20180—
+7K180925uMR 570Shanghai United Imaging Healthcare Co., Ltd.20187—
+7K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+7K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+7K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+7K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+7K173467Advanced Diffusion Analysis (ADA) applicationPhilips Medical Systems Nederland B.V.20170—
+7K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.20170—
+7K170840MAGNETOM TerraSiemens Medical Solutions USA, Inc.20172—
+7K170580Carestream Vue PACSCarestream Health, Inc.20171—
+7K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+7K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc.201684Class I
+7K153447MAGNETOM SpectraSiemens Medical Solutions USA, Inc.201601
+7K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma…Siemens Medical Solutions USA, Inc.201585Class I
+7K143020LiverMultiScanMirada Medical, Ltd.20158—
+7K150069Fine Structure Analysis (fineSA)Acuitas Medical, Ltd.20150—
+7K150843syngo®.via (version VB10A)Siemens AG201546—
+7K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+7K142515MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite…Siemens Medical Solutions USA, Inc.20140—
+7K133401Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR GeneralSiemens Medical Solutions USA, Inc.201427—
+7K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc.201312Class I
+7K133226Biograph MMRSiemens Medical Solutions USA, Inc.2013201
+8K253794Prostate CoreLucida Medical, Ltd.20260—
+8K253421Perfusion Measurement Platform v1Quantified Imaging Limited20260—
+8K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+8K253023BIOGRAPH OneSiemens Healthineers AG20260—
+8K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+8K243680Neurovascular Insight V1.0Olea Medical S.A.S.20250—
+8K230294CoverScan (CoverScan v1.1)Perspectum20230—
+8K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+8K220349TeraRecon NeuroTerarecon,Inc.20220—
+8K220575MAGNETOM Free.Max, MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.202231
+8K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—