510(k) Report

Devices descending from K050200

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+6K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+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—
+6K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+6K163312MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 SoftwareSiemens Medical Solutions USA, Inc.20174—
+6K161201ClearRead CTRiverain Technologies, LLC20165—
+6K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+6K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+6K151353syngo.MR Neurology, syngo.MR OncologySiemens Medical Solutions USA, Inc.201525—
+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
+6K140897Syngo.MR Neurology, Syngo.MMR GeneralSiemens Medical Solutions USA, Inc.20140—
+6K133521Aze Phoenix SoftwareAze, Ltd.20140—
+6K130998Syngo.Via Web ViewerSiemens AG Medical Solutions20140—
+6K132523MyoperfusionToshibamedical Systems Corporation201311
+6K132532Syngo.Plaza VB10ASiemens AG Healthcare2013811
+6K123522Optima MR450WGe Healthcare (Ge Medical Systems, LLC)2013431
+6K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+6K1233271.5T Gem RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.)20132—
+6K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+6K113620Myrian 1.11Intrasense20126—
+6K112531Vitrea CT Myocardial AnalysisVital Images, Inc.20116—
+7K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+7K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+7K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+7K242919V5med Lung AIV5med, Inc.20250—
+7K250379SIGNA Prime EliteGe Medical Systems, LLC20250—
+7K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+7K241211CoLumboSmart Soft Healthcare20242—
+7K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+7K233080HealthFLDNano-X AI, Ltd.20240—
+7K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+7K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+7K223343MAGNETOM Amira; MAGNETOM SempraSiemens Medical Solutions USA, Inc.202301
+7K221612ClearRead CTRiverain Technologies, Inc.20220—
+7K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20221—
+7K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+7K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+7K220497CoLumboSmart Soft Healthcare AD20226—
+7K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+7K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+7K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+7K210611MAGNETOM Free.MaxSiemens Medical Solutions USA, Inc.202141
+7K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+7K201250SQuEEZ SoftwareCardiowise, Inc.20200—
+7K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+7K201540uMR570Shanghai United Imaging Healthcare Co., Ltd.20205—
+7K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+7K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+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—
+7K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+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—
+7K180563syngo.plazaSiemens Healthcare GmbH20180—
+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—
+7K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+7K162722HyperSenseGe Medical Systems, LLC20170—
+7K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+7K161567SIGNA VoyagerGE Healthcare201644
+7K161397MAGiCGe Medical Systems, LLC20161—
+7K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+7K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5TGe Medical Systems, LLC20161640
+7K143345SIGNA PioneerGe Healthcare Japan Corporation2015156
+7K142750JiveXVisus Technology Transfer GmbH20156—
+7K150104Vitrea CT Myocardial PerfusionVital Images, Inc.20150—
+7K1433893.0T GEM RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.)20151—
+7K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+7K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+8K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+8K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+8K250367CoLumboXSmart Soft Healthcare AD20250—
+8K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+8K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+8K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+8K240793MSKaiMskai20240—
+8K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+8K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+8K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20240—
+8K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+8K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+8K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+8K230758uMR 570Shanghai United Imaging Healthcare Co., Ltd.20230—
+8K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+8K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+8K222755uMR 680Shanghai United Imaging Intelligence Co., Ltd.20233—
+8K220332uMR Omega with uWS-MR-MRSShanghai United Imaging Healthcare Co., Ltd.20227—
+8K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+8K220575MAGNETOM Free.Max, MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.202231
+8K21368732Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head…Neocoil, LLC20220—