510(k) Report

Devices descending from K062454

308 later devices reach Magnetom Systems - I-Class and T-Class Releases through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A.20240—
+5K232322MAGNETOM Terra; MAGNETOM Terra.XSiemens Medical Solutions USA, Inc.20240—
+5K230294CoverScan (CoverScan v1.1)Perspectum20230—
+5K2232031.5T 24E Posterior ArrayShenzhen RF Tech Co., Ltd.20230—
+5K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+5K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+5K210415QSM software, QSMetricMedimagemetric, LLC20210—
+5K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+5K201948AcroDTI VisualizerAcroviz, Inc.20200—
+5K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+5K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+5K200327EvrySynaptive Medical, Inc.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—
+5K183014uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20193—
+5K183221MAGNETOM Amira, MAGNETOM SempraSiemens Medical Solutions USA, Inc.201961
+5K182129MAGNETOM SolaSiemens Medical Solutions USA, Inc.20181—
+5K181322MAGNETOM SolaSiemens Medical Solutions USA, Inc.20188—
+5K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+5K173224Spin-SwiSpintech, Inc.20183—
+5K173592MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM AvantofitSiemens Medical Solutions USA, Inc.20183Class I
+5K172685LiverMultiScanPerspectum Diagnostics, Ltd.20177—
+5K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc.201730Class I
+5K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+5K163619Signa Pet/MRGe Medical Systems, LLC201717
+5K163312MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 SoftwareSiemens Medical Solutions USA, Inc.20174—
+5K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+5K151212Ziostation2Qi Imaging, LLC20152—
+5K151353syngo.MR Neurology, syngo.MR OncologySiemens Medical Solutions USA, Inc.201525—
+5K143251SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC)2015314
+5K140897Syngo.MR Neurology, Syngo.MMR GeneralSiemens Medical Solutions USA, Inc.20140—
+5K132376Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5TGe Healthcare (Ge Medical Systems, LLC)20134215
+5K120778Brivo MR355Ge Hangwei Medical Systems Co., Ltd.201204
+5K113490Optima MR450WGe Medical Systems, LLC2012443
+5K103335Gem Option for 1.5 Mri SystemsGE Healthcare201133
+6K252571mdprostateMediaire GmbH20260—
+6K253690LungMapsSiemens Healthineers AG20260—
+6K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+6K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+6K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+6K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+6K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+6K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+6K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+6K232981Synq Software Version 1.3Synaptive Medical, Inc.20230—
+6K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+6K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+6K223343MAGNETOM Amira; MAGNETOM SempraSiemens Medical Solutions USA, Inc.202301
+6K223439SIGNA VictorGe Healthcare (Tianjin) Company Limited202311
+6K220349TeraRecon NeuroTerarecon,Inc.20220—
+6K203279Veuron-Brain-mN1Heuron Co., Ltd.20220—
+6K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+6K213709Signa Pet/MRGe Medical Systems, LLC202203
+6K211980SIGNA PrimeGe Healthcare (Tianjin) Company Limited202222
+6K210611MAGNETOM Free.MaxSiemens Medical Solutions USA, Inc.202141
+6K210843STAGESpintech, Inc.20211—
+6K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+6K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+6K201540uMR570Shanghai United Imaging Healthcare Co., Ltd.20205—
+6K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+6K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+6K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+6K193176uMR 780Shanghai United Imaging Healthcare Co., Ltd.20200—
+6K193200uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20208—
+6K192496Magnetom Sola, Magnetom Altea and Magnetom Sola FitSiemens Medical Solutions USA, Inc.20200—
+6K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20192—
+6K190017LiverMultiScan (LMSv3)Perspectum Diagnostics, Ltd.20196—
+6K190757MAGNETOM Avanto FitSiemens Medical Solution USA, Inc.20190—
+6K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+6K182299MAGNETOM AeraSiemens Medical Solutions USA, Inc.20181—
+6K181433MAGNETOM VidaSiemens Medical Solutions USA, Inc.201828—
+6K173617MAGNETOM Vida with Compressed Sensing GRASP-VIBESiemens Medical Solutions USA, Inc.20180—
+6K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+6K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+6K142361Discovery MR750 3.0TGe Medical Systems, LLC201402
+6K142085Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W 1.5TGe Medical Systems, LLC20144027
+6K123522Optima MR450WGe Healthcare (Ge Medical Systems, LLC)2013431
+6K1233271.5T Gem RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.)20132—
+7K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+7K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+7K250379SIGNA Prime EliteGe Medical Systems, LLC20250—
+7K241211CoLumboSmart Soft Healthcare20242—
+7K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+7K230758uMR 570Shanghai United Imaging Healthcare Co., Ltd.20230—
+7K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+7K222755uMR 680Shanghai United Imaging Intelligence Co., Ltd.20233—
+7K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20221—
+7K223079StageSpintech, Inc.20220—
+7K220332uMR Omega with uWS-MR-MRSShanghai United Imaging Healthcare Co., Ltd.20227—
+7K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+7K220575MAGNETOM Free.Max, MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.202231
+7K220497CoLumboSmart Soft Healthcare AD20226—
+7K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—