510(k) Report

Devices descending from K050200

428 later devices reach Magnetom Trio a Tim System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K230552MR DWI/FLAIR Measurement V1.0Olea Medical20230—
+5K211059CereFlow™ V1.2Translational Mri, LLC20231—
+5K2232031.5T 24E Posterior ArrayShenzhen RF Tech Co., Ltd.20230—
+5K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+5K223502MR Diffusion Perfusion Mismatch V1.0Olea Medical20230—
+5K212565CoverScan v1Perspectum, Ltd.20221—
+5K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+5K212777Collaboration LivePhilips Ultrasound, Inc.20211—
+5K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+5K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L.20211—
+5K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+5K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+5K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+5K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.20201Class I
+5K200327EvrySynaptive Medical, Inc.20201—
+5K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+5K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+5K193116MRopen EVOAsg Superconductors S.P.A.20191—
+5K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+5K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20191—
+5K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+5K183014uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20193—
+5K183222MAGNETOM TerraSiemens Medical Solutions USA, Inc.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—
+5K181371uMR 790Shanghai United Imaging Healthcare Co., Ltd.201811—
+5K180926uMR 560Shanghai United Imaging Healthcare Co., Ltd.20180—
+5K180925uMR 570Shanghai United Imaging Healthcare Co., Ltd.20187—
+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—
+5K173600MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20177—
+5K173467Advanced Diffusion Analysis (ADA) applicationPhilips Medical Systems Nederland B.V.20170—
+5K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.20170—
+5K170580Carestream Vue PACSCarestream Health, Inc.20171—
+5K163619Signa Pet/MRGe Medical Systems, LLC201717
+5K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+5K163211MAGNETOM Sempra with syngo MR E11SSiemens Medical Solutions USA, Inc.20177—
+5K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc.201684Class I
+5K151212Ziostation2Qi Imaging, LLC20152—
+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—
+5K143251SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC)2015314
+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—
+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
+5K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+5K113490Optima MR450WGe Medical Systems, LLC2012443
+5K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+5K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+5K111079Syngo.Via Web ViewerSiemens AG Medical Solutions20111—
+5K110366Syngo.CT Cardiac FunctionSiemens AG2011251
+5K103335Gem Option for 1.5 Mri SystemsGE Healthcare201133
+5K101666Syngo. Plaza VA20ASiemens AG Medical Solutions201093
+5K100637Syngo.CT Coronary AnalysisSiemens AG Medical Solutions20102—
+5K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+6K253794Prostate CoreLucida Medical, Ltd.20260—
+6K252571mdprostateMediaire GmbH20260—
+6K253421Perfusion Measurement Platform v1Quantified Imaging Limited20260—
+6K253690LungMapsSiemens Healthineers AG20260—
+6K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+6K253023BIOGRAPH OneSiemens Healthineers AG20260—
+6K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+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—
+6K241302SonoSyncSamsung Medison Co., Ltd.20240—
+6K232322MAGNETOM Terra; MAGNETOM Terra.XSiemens Medical Solutions USA, Inc.20240—
+6K232981Synq Software Version 1.3Synaptive Medical, Inc.20230—
+6K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+6K223424Spine Auto ViewsGE Medical Systems SCS20230—
+6K230294CoverScan (CoverScan v1.1)Perspectum20230—
+6K223439SIGNA VictorGe Healthcare (Tianjin) Company Limited202311
+6K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+6K220349TeraRecon NeuroTerarecon,Inc.20220—
+6K213944HealthOSTNanoxai, Ltd.20221—
+6K213709Signa Pet/MRGe Medical Systems, LLC202203
+6K211980SIGNA PrimeGe Healthcare (Tianjin) Company Limited202222
+6K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+6K201948AcroDTI VisualizerAcroviz, Inc.20200—
+6K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+6K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+6K200024uMR 570Shanghai United Imaging Healthcare Co., Ltd.20206—
+6K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20192—
+6K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+6K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+6K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+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—
+6K183221MAGNETOM Amira, MAGNETOM SempraSiemens Medical Solutions USA, Inc.201961
+6K182129MAGNETOM SolaSiemens Medical Solutions USA, Inc.20181—
+6K181322MAGNETOM SolaSiemens Medical Solutions USA, Inc.20188—