510(k) Report

Devices descending from K971684

442 later devices reach Magnetom Project 047 System (Numaris 3.5 Software) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K133435Magnetom Aera and Skyra with Software MR D13ASiemens Medical Solutions USA, Inc.20130—
+5K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc.201312Class I
+5K132951Magnetom AeraSiemens Medical Solutions USA, Inc.201391
+5K133226Biograph MMRSiemens Medical Solutions USA, Inc.2013201
+5K132831Quiet/Silent Scanning SuiteSiemens Medical Solutions USA, Inc.20130—
+5K130749Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc.201354—
+5K123510Magnetom SkyraSiemens Medical Solutions USA, Inc.201316—
+5K123920Syngo.ViaSiemens AG Medical Solutions201363—
+5K123068Optima MR 430SGe Medical Systems, LLC201202
+5K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+5K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+5K103327Discovery MR750W 3.0TGe Healthcare Japan Corporation2011526
+5K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+5K111079Syngo.Via Web ViewerSiemens AG Medical Solutions20111—
+5K110366Syngo.CT Cardiac FunctionSiemens AG2011251
+5K101666Syngo. Plaza VA20ASiemens AG Medical Solutions201093
+5K100637Syngo.CT Coronary AnalysisSiemens AG Medical Solutions20102—
+5K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+5K083147Discovery MR450Ge Medical Systems, LLC20086910
+6K253963Cubresa BrainPETCubresa, Inc.20260—
+6K243681Neuro Insight V1.0Olea Medical S.A.S.20250—
+6K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+6K241302SonoSyncSamsung Medison Co., Ltd.20240—
+6K223424Spine Auto ViewsGE Medical Systems SCS20230—
+6K223091CT Perfusion V1.0Olea Medical20230—
+6K223532Olea S.I.A. Neurovascular V1.0Olea Medical20231—
+6K230552MR DWI/FLAIR Measurement V1.0Olea Medical20230—
+6K211059CereFlow™ V1.2Translational Mri, LLC20231—
+6K223343MAGNETOM Amira; MAGNETOM SempraSiemens Medical Solutions USA, Inc.202301
+6K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+6K223502MR Diffusion Perfusion Mismatch V1.0Olea Medical20230—
+6K223079StageSpintech, Inc.20220—
+6K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+6K212565CoverScan v1Perspectum, Ltd.20221—
+6K213944HealthOSTNanoxai, Ltd.20221—
+6K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+6K210611MAGNETOM Free.MaxSiemens Medical Solutions USA, Inc.202141
+6K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L.20211—
+6K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+6K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+6K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+6K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.20201Class I
+6K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+6K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+6K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+6K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20191—
+6K183222MAGNETOM TerraSiemens Medical Solutions USA, Inc.20191—
+6K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+6K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+6K181370uMR 780Shanghai United Imaging Healthcare Co., Ltd.201811—
+6K181371uMR 790Shanghai United Imaging Healthcare Co., Ltd.201811—
+6K180926uMR 560Shanghai United Imaging Healthcare Co., Ltd.20180—
+6K180925uMR 570Shanghai United Imaging Healthcare Co., Ltd.20187—
+6K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+6K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+6K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+6K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+6K173467Advanced Diffusion Analysis (ADA) applicationPhilips Medical Systems Nederland B.V.20170—
+6K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.20170—
+6K170580Carestream Vue PACSCarestream Health, Inc.20171—
+6K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+6K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+6K161201ClearRead CTRiverain Technologies, LLC20165—
+6K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc.201684Class I
+6K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma…Siemens Medical Solutions USA, Inc.201585Class I
+6K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+6K143020LiverMultiScanMirada Medical, Ltd.20158—
+6K150069Fine Structure Analysis (fineSA)Acuitas Medical, Ltd.20150—
+6K150843syngo®.via (version VB10A)Siemens AG201546—
+6K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+6K142098Signa Pet/MRGe Medical Systems, LLC201466
+6K142515MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite…Siemens Medical Solutions USA, Inc.20140—
+6K133521Aze Phoenix SoftwareAze, Ltd.20140—
+6K133401Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR GeneralSiemens Medical Solutions USA, Inc.201427—
+6K130998Syngo.Via Web ViewerSiemens AG Medical Solutions20140—
+6K132523MyoperfusionToshibamedical Systems Corporation201311
+6K132532Syngo.Plaza VB10ASiemens AG Healthcare2013811
+6K130115Discovery MR750W 3.0TGe Medical Systems, LLC2013431
+6K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+6K123417Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd.201356
+6K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+6K1216761.5T Signa HDXT 3.0T Signa HDXT Signa VibrantGe Medical Systems, LLC2012510
+6K113620Myrian 1.11Intrasense20126—
+6K112531Vitrea CT Myocardial AnalysisVital Images, Inc.20116—
+6K103330Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd.201176
+6K091536Optima MR450WGe Medical Systems, LLC2009598
+7K253794Prostate CoreLucida Medical, Ltd.20260—
+7K252571mdprostateMediaire GmbH20260—
+7K253421Perfusion Measurement Platform v1Quantified Imaging Limited20260—
+7K253690LungMapsSiemens Healthineers AG20260—
+7K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+7K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+7K253023BIOGRAPH OneSiemens Healthineers AG20260—
+7K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+7K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+7K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+7K243680Neurovascular Insight V1.0Olea Medical S.A.S.20250—
+7K242919V5med Lung AIV5med, Inc.20250—
+7K232322MAGNETOM Terra; MAGNETOM Terra.XSiemens Medical Solutions USA, Inc.20240—
+7K233080HealthFLDNano-X AI, Ltd.20240—