510(k) Report

Devices descending from K041112

422 later devices reach Magnetom Espree System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma…Siemens Medical Solutions USA, Inc.201585Class I
+4K143020LiverMultiScanMirada Medical, Ltd.20158—
+4K150069Fine Structure Analysis (fineSA)Acuitas Medical, Ltd.20150—
+4K150843syngo®.via (version VB10A)Siemens AG201546—
+4K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+4K142515MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite…Siemens Medical Solutions USA, Inc.20140—
+4K133401Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR GeneralSiemens Medical Solutions USA, Inc.201427—
+4K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc.201312Class I
+4K133226Biograph MMRSiemens Medical Solutions USA, Inc.2013201
+4K131299Anythink Pacs WorkstationBeijing Crealife Technology Co., Ltd.20130—
+4K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+4K123068Optima MR 430SGe Medical Systems, LLC201202
+4K103327Discovery MR750W 3.0TGe Healthcare Japan Corporation2011526
+4K092519Syngo.XSiemens AG Medical Solutions20091764
+4K083147Discovery MR450Ge Medical Systems, LLC20086910
+5K253794Prostate CoreLucida Medical, Ltd.20260—
+5K252571mdprostateMediaire GmbH20260—
+5K253421Perfusion Measurement Platform v1Quantified Imaging Limited20260—
+5K253690LungMapsSiemens Healthineers AG20260—
+5K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+5K253023BIOGRAPH OneSiemens Healthineers AG20260—
+5K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+5K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+5K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+5K243680Neurovascular Insight V1.0Olea Medical S.A.S.20250—
+5K223261Open RibCanon Medical Informatics, Inc.20230—
+5K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+5K230294CoverScan (CoverScan v1.1)Perspectum20230—
+5K220349TeraRecon NeuroTerarecon,Inc.20220—
+5K212777Collaboration LivePhilips Ultrasound, Inc.20211—
+5K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+5K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+5K201948AcroDTI VisualizerAcroviz, Inc.20200—
+5K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+5K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+5K200024uMR 570Shanghai United Imaging Healthcare Co., Ltd.20206—
+5K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+5K193116MRopen EVOAsg Superconductors S.P.A.20191—
+5K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+5K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+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—
+5K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+5K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+5K183222MAGNETOM TerraSiemens Medical Solutions USA, Inc.20191—
+5K182129MAGNETOM SolaSiemens Medical Solutions USA, Inc.20181—
+5K181322MAGNETOM SolaSiemens Medical Solutions USA, Inc.20188—
+5K181371uMR 790Shanghai United Imaging Healthcare Co., Ltd.201811—
+5K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+5K173592MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM AvantofitSiemens Medical Solutions USA, Inc.20183Class I
+5K173600MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20177—
+5K172685LiverMultiScanPerspectum Diagnostics, Ltd.20177—
+5K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc.201730Class I
+5K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+5K163211MAGNETOM Sempra with syngo MR E11SSiemens Medical Solutions USA, Inc.20177—
+5K163312MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 SoftwareSiemens Medical Solutions USA, Inc.20174—
+5K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+5K151353syngo.MR Neurology, syngo.MR OncologySiemens Medical Solutions USA, Inc.201525—
+5K142098Signa Pet/MRGe Medical Systems, LLC201466
+5K140897Syngo.MR Neurology, Syngo.MMR GeneralSiemens Medical Solutions USA, Inc.20140—
+5K131241SWIPPhilips Medical Systems Nederland B.V.20135—
+5K130115Discovery MR750W 3.0TGe Medical Systems, LLC2013431
+5K123417Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd.201356
+5K1216761.5T Signa HDXT 3.0T Signa HDXT Signa VibrantGe Medical Systems, LLC2012510
+5K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+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
+5K103330Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd.201176
+5K101666Syngo. Plaza VA20ASiemens AG Medical Solutions201093
+5K100637Syngo.CT Coronary AnalysisSiemens AG Medical Solutions20102—
+5K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+5K091536Optima MR450WGe Medical Systems, LLC2009598
+6K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+6K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+6K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A.20240—
+6K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+6K241302SonoSyncSamsung Medison Co., Ltd.20240—
+6K241211CoLumboSmart Soft Healthcare20242—
+6K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+6K232322MAGNETOM Terra; MAGNETOM Terra.XSiemens Medical Solutions USA, Inc.20240—
+6K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+6K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+6K223424Spine Auto ViewsGE Medical Systems SCS20230—
+6K2232031.5T 24E Posterior ArrayShenzhen RF Tech Co., Ltd.20230—
+6K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+6K220497CoLumboSmart Soft Healthcare AD20226—
+6K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+6K213944HealthOSTNanoxai, Ltd.20221—
+6K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+6K210415QSM software, QSMetricMedimagemetric, LLC20210—
+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—
+6K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+6K193176uMR 780Shanghai United Imaging Healthcare Co., Ltd.20200—
+6K200327EvrySynaptive Medical, Inc.20201—