510(k) Report

Devices descending from K002179

241 later devices reach Magnetom Allegra System 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—
+1K021330Magnetom Trio Quadrature TX/RX Head CoilUsa Instruments, Inc.2002222—
+1K020991Syngo MR 2002BSiemens Medical Solutions USA, Inc.200262
+1K021262Magnetom Symphony Quadrature TX/RX Head CoilUsa Instruments, Inc.2002219—
+2K10274831P/1H Head Coil 3T; 23NA/1H Head Coil 3T; 13C/1H Head Coil 3TRapid Biomedical GmbH20111—
+2K10234831P/1H Dual Tuned Surface Coil 3T; 23NA/ 1H Dual Turned Surface Coil 3T; 13C /1H Dual…Rapid Biomedical GmbH20100—
+2K091114TXRX 1.5T CP Head Coil; TXRX 3T CP Head CoilQuality Electrodynamics2009217—
+2K082636TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TQuality Electrodynamics2008218
+2K061281Insight Head CoilInsight Neuroimaging Systems, LLC20060—
+2K050132Neuro II-SInnovative Magnetic Resonance Imaging Systems, Inc.20050—
+2K04271813C/1H Occipital Headcoil for Magnetom AllegraSiemens Medi Cal Solutions, Inc.20041—
+2K040937Tem 3000 Head CoilMr Instruments, Inc.20041—
+2K033235Gemini Iii Hybrid TX/RX 4 Channel Head CoilUsa Instruments, Inc.20030—
+3K21348031P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head CoilRapid Biomedical GmbH20230—
+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—
+3K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc.2012215Class I
+3K120627Toshiba 1.5T QD Head CoilQuality Electrodynamics20120—
+3K10014114-Channel Extremity Coil for Magnetom EssenzaSiemens Medical Solutions USA, Inc.201012—
+3K080820Tem 3002G- HN Dual Tune Head CoilMr Instruments, Inc.20080—
+4K191050MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease…Siemens Medical Solutions USA, Inc.20190—
+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—
+4K16262316ch T/R Hand Wrist CoilQuality Electrodynamics, LLC20161—
+4K16202916ch T/R Knee CoilQuality Electrodynamics, LLC20160—
+4K152602Olea Sphere V3.0Olea Medical201617—
+4K15175316 ch Tx/Rx Knee SPEEDERQuality Electrodynamics, LLC20151—
+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—
+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
+4K130262Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc.201311—
+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—
+5K223502MR Diffusion Perfusion Mismatch V1.0Olea Medical20230—
+5K212565CoverScan v1Perspectum, Ltd.20221—
+5K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+5K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L.20211—
+5K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.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—
+5K17346916ch T/R Hand Wrist CoilQuality Electrodynamics, LLC20180—
+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—
+5K161795Magnetom EssenzaSiemens Medical Solutions USA, Inc.20160—
+5K16119316ch Tx/Rx Knee SPEEDERQuality Electrodynamics, LLC20160—
+5K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc.201684Class I
+5K153447MAGNETOM SpectraSiemens Medical Solutions USA, Inc.201601
+5K152283MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20159—
+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—
+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