510(k) Report

Devices descending from K032428

431 later devices reach Magnetom Avanto MR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190524MRopen 0.5 TAsg Superconductors S.P.A.20192—
+1K083166Specialty Coils for the Magnetom EssenzaSiemens Medical Solutions USA, Inc.2009222—
+1K0729091.5T 32-Channel Head Coil and 3T 32-Channel Head CoilSiemens AG Medical Solutions20070—
+1K071925Magnetom EssenzaSiemens Medical Solutions USA, Inc.20072281
+1K063373Flex Loop Coil Set 3TSiemens AG20064—
+1K062454Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc.2006308—
+1K052423Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc.2006199—
+1K052164Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc.2005312—
+1K050200Magnetom Trio a Tim SystemSiemens Medical Solutions USA, Inc.20054283
+1K050199Magnetom Symphony a Tim SystemSiemens Medical Solution2005422—
+1K041112Magnetom Espree SystemSiemens Medical Solutions USA, Inc.20044224
+2K233660nCommand Lite SystemIonic Health20240—
+2K232346Digital Expert Access with Remote ScanningGE Healthcare20230—
+2K193116MRopen EVOAsg Superconductors S.P.A.20191—
+2K150193Customer Remote Console (CRC)Ge Medical Systems, LLC201512—
+2K131241SWIPPhilips Medical Systems Nederland B.V.20135—
+2K130262Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc.201311—
+2K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+2K111242Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc.20112203
+2K103275Specialty Coils for Magnetom Aera 1.5T & Magnetim Skyra 3T MR SystemsSiemens Medical Solutions USA, Inc.2011221—
+2K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc.2010224Class I
+2K092237NSM-S15 SystemNeusoft Medical Systems Co., Ltd.20090—
+2K083578Noras CPC Multifunctional CoilNoras Mri Products GmbH20091—
+2K082427Syngo MR B17Siemens Medical Solutions USA, Inc.2008229—
+2K082331Magnetom C!Siemens Medical Solutions USA, Inc.20083—
+2K080048MSK Extreme MR Scanner, Model AA5000Oni Medical Systems, Inc.200823
+2K072237Magnetom VerioSiemens Medical Solutions USA, Inc.2007300Class I
+2K070629Flex and Loop Coil Set 1.5 TSiemens Medical Solutions20071—
+2K061964Syngo Multimodality WorkplaceSiemens AG Medical Solutions2006180—
+2K061449Syngo Expert-1Siemens Medical Solution200613—
+3K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A.20240—
+3K232744syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH20234—
+3K210415QSM software, QSMetricMedimagemetric, LLC20210—
+3K200179Collaboration LivePhilips Health Care20204—
+3K181892Ziostation2Ziosoft, Inc.20181—
+3K173224Spin-SwiSpintech, Inc.20183—
+3K161795Magnetom EssenzaSiemens Medical Solutions USA, Inc.20160—
+3K152283MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20159—
+3K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+3K14025216 CH Multipurpose Coil VarietyNoras Rontgen-Und Medizintechnik GmbH20140—
+3K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+3K130885Magnetom Avanto-Fit, Magnetom Skyra-FitSiemens Medical Solutions USA, Inc.20130Class I
+3K123938Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree, Syngo MR B19 for…Siemens Medical Solutions USA, Inc.201338—
+3K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc.2012215Class I
+3K121160Magnetom SpectraSiemens Medical Solutions USA, Inc.20121Class I
+3K121459Syngo.MR NeurologySiemens Medical Solutions USA, Inc.20123—
+3K120315Syngo.MR Spectro Engine, Syngo.MR Spectro SVS, Syngo.MR Spectro Csi, Syngo.MR Spectro…Siemens Medical Solutions USA, Inc.201223—
+3K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+3K103429Biograph MMRSiemens Medical Solutions USA, Inc.2011211
+3K110373Temporomanibular Coil 15Esaote, S.p.A.20110—
+3K1032381.5T Optima MR430SGe Medical Systems, LLC201112
+3K0929253D ASLGe Medical Systems, LLC20100—
+3K081734Syngo Imaging (Version V31)Siemens AG Medical Solutions20081775
+3K081028Signa 3.0T MR750 SystemGe Medical Systems, LLC20087011
+3K072728Syngo Multimodality WorkplaceSiemens AG Medical Solutions2008178—
+4K243666uOmniscanShanghai United Imaging Healthcare Co., Ltd.20250—
+4K243703TechLiveDeepHealth, Inc.20250—
+4K243333rTOPRoclub GmbH20250—
+4K242329CT Collaboration LivePhilips Healthcare (Suzhou) Co., Ltd.20240—
+4K242512ROCC ConsolePhilips Medical Systems Nederland B.V.20240—
+4K231133neo315Neoscan Solution GmbH20240—
+4K230856BrainSpec Core™ SoftwareBrainspec, Inc.20230—
+4K203279Veuron-Brain-mN1Heuron Co., Ltd.20220—
+4K210843STAGESpintech, Inc.20211—
+4K201665Collaboration LivePhilips Ultrasound, Inc.20202—
+4K200315Ziostation2Ziosoft, Inc.20200—
+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
+4K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+4K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+4K173600MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20177—
+4K170840MAGNETOM TerraSiemens Medical Solutions USA, Inc.20172—
+4K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc.201712—
+4K163211MAGNETOM Sempra with syngo MR E11SSiemens Medical Solutions USA, Inc.20177—
+4K153447MAGNETOM SpectraSiemens Medical Solutions USA, Inc.201601
+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—
+4K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc.201312Class I
+4K132951Magnetom AeraSiemens Medical Solutions USA, Inc.201391
+4K133226Biograph MMRSiemens Medical Solutions USA, Inc.2013201
+4K132831Quiet/Silent Scanning SuiteSiemens Medical Solutions USA, Inc.20130—
+4K130749Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc.201354—
+4K131299Anythink Pacs WorkstationBeijing Crealife Technology Co., Ltd.20130—
+4K123510Magnetom SkyraSiemens Medical Solutions USA, Inc.201316—
+4K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+4K123920Syngo.ViaSiemens AG Medical Solutions201363—
+4K123068Optima MR 430SGe Medical Systems, LLC201202
+4K103327Discovery MR750W 3.0TGe Healthcare Japan Corporation2011526
+4K092519Syngo.XSiemens AG Medical Solutions20091764
+4K083147Discovery MR450Ge Medical Systems, LLC20086910
+5K253963Cubresa BrainPETCubresa, Inc.20260—
+5K243681Neuro Insight V1.0Olea Medical S.A.S.20250—
+5K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+5K223261Open RibCanon Medical Informatics, Inc.20230—
+5K223091CT Perfusion V1.0Olea Medical20230—
+5K223532Olea S.I.A. Neurovascular V1.0Olea Medical20231—