510(k) Report

Devices descending from K052164

312 later devices reach Magnetom Systems with Software Syngo MR 2006A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+6K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A.20240—
+6K232322MAGNETOM Terra; MAGNETOM Terra.XSiemens Medical Solutions USA, Inc.20240—
+6K230294CoverScan (CoverScan v1.1)Perspectum20230—
+6K2232031.5T 24E Posterior ArrayShenzhen RF Tech Co., Ltd.20230—
+6K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+6K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+6K210415QSM software, QSMetricMedimagemetric, LLC20210—
+6K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+6K201948AcroDTI VisualizerAcroviz, Inc.20200—
+6K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+6K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+6K200327EvrySynaptive Medical, Inc.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—
+6K183014uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20193—
+6K183221MAGNETOM Amira, MAGNETOM SempraSiemens Medical Solutions USA, Inc.201961
+6K182129MAGNETOM SolaSiemens Medical Solutions USA, Inc.20181—
+6K181322MAGNETOM SolaSiemens Medical Solutions USA, Inc.20188—
+6K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+6K173224Spin-SwiSpintech, Inc.20183—
+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
+6K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+6K163619Signa Pet/MRGe Medical Systems, LLC201717
+6K163312MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 SoftwareSiemens Medical Solutions USA, Inc.20174—
+6K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+6K151212Ziostation2Qi Imaging, LLC20152—
+6K151353syngo.MR Neurology, syngo.MR OncologySiemens Medical Solutions USA, Inc.201525—
+6K143251SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC)2015314
+6K140897Syngo.MR Neurology, Syngo.MMR GeneralSiemens Medical Solutions USA, Inc.20140—
+6K132376Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5TGe Healthcare (Ge Medical Systems, LLC)20134215
+6K120778Brivo MR355Ge Hangwei Medical Systems Co., Ltd.201204
+6K113490Optima MR450WGe Medical Systems, LLC2012443
+6K103335Gem Option for 1.5 Mri SystemsGE Healthcare201133
+7K252571mdprostateMediaire GmbH20260—
+7K253690LungMapsSiemens Healthineers AG20260—
+7K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+7K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+7K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+7K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+7K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+7K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+7K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+7K232981Synq Software Version 1.3Synaptive Medical, Inc.20230—
+7K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+7K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+7K223343MAGNETOM Amira; MAGNETOM SempraSiemens Medical Solutions USA, Inc.202301
+7K223439SIGNA VictorGe Healthcare (Tianjin) Company Limited202311
+7K220349TeraRecon NeuroTerarecon,Inc.20220—
+7K203279Veuron-Brain-mN1Heuron Co., Ltd.20220—
+7K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+7K213709Signa Pet/MRGe Medical Systems, LLC202203
+7K211980SIGNA PrimeGe Healthcare (Tianjin) Company Limited202222
+7K210611MAGNETOM Free.MaxSiemens Medical Solutions USA, Inc.202141
+7K210843STAGESpintech, Inc.20211—
+7K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+7K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+7K201540uMR570Shanghai United Imaging Healthcare Co., Ltd.20205—
+7K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+7K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+7K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+7K193176uMR 780Shanghai United Imaging Healthcare Co., Ltd.20200—
+7K193200uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20208—
+7K192496Magnetom Sola, Magnetom Altea and Magnetom Sola FitSiemens Medical Solutions USA, Inc.20200—
+7K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20192—
+7K190017LiverMultiScan (LMSv3)Perspectum Diagnostics, Ltd.20196—
+7K190757MAGNETOM Avanto FitSiemens Medical Solution USA, Inc.20190—
+7K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+7K182299MAGNETOM AeraSiemens Medical Solutions USA, Inc.20181—
+7K181433MAGNETOM VidaSiemens Medical Solutions USA, Inc.201828—
+7K173617MAGNETOM Vida with Compressed Sensing GRASP-VIBESiemens Medical Solutions USA, Inc.20180—
+7K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+7K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+7K142361Discovery MR750 3.0TGe Medical Systems, LLC201402
+7K142085Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W 1.5TGe Medical Systems, LLC20144027
+7K123522Optima MR450WGe Healthcare (Ge Medical Systems, LLC)2013431
+7K1233271.5T Gem RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.)20132—
+8K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+8K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+8K250379SIGNA Prime EliteGe Medical Systems, LLC20250—
+8K241211CoLumboSmart Soft Healthcare20242—
+8K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+8K230758uMR 570Shanghai United Imaging Healthcare Co., Ltd.20230—
+8K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+8K222755uMR 680Shanghai United Imaging Intelligence Co., Ltd.20233—
+8K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20221—
+8K223079StageSpintech, Inc.20220—
+8K220332uMR Omega with uWS-MR-MRSShanghai United Imaging Healthcare Co., Ltd.20227—