510(k) Report

Devices descending from K010570

254 later devices reach Breast Immobiization and Biopsy Device MR-Biopsy 160 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K133226Biograph MMRSiemens Medical Solutions USA, Inc.2013201
+7K253794Prostate CoreLucida Medical, Ltd.20260—
+7K253421Perfusion Measurement Platform v1Quantified Imaging Limited20260—
+7K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+7K253023BIOGRAPH OneSiemens Healthineers AG20260—
+7K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+7K243680Neurovascular Insight V1.0Olea Medical S.A.S.20250—
+7K230294CoverScan (CoverScan v1.1)Perspectum20230—
+7K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+7K220349TeraRecon NeuroTerarecon,Inc.20220—
+7K220575MAGNETOM Free.Max, MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.202231
+7K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+7K201948AcroDTI VisualizerAcroviz, Inc.20200—
+7K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+7K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+7K200024uMR 570Shanghai United Imaging Healthcare Co., Ltd.20206—
+7K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+7K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+7K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+7K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+7K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+7K191157uMR 780, uMR 790Shanghai United Imaging Healthcare Co., Ltd.201910—
+7K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+7K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+7K183222MAGNETOM TerraSiemens Medical Solutions USA, Inc.20191—
+7K182129MAGNETOM SolaSiemens Medical Solutions USA, Inc.20181—
+7K181322MAGNETOM SolaSiemens Medical Solutions USA, Inc.20188—
+7K181371uMR 790Shanghai United Imaging Healthcare Co., Ltd.201811—
+7K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+7K173592MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM AvantofitSiemens Medical Solutions USA, Inc.20183Class I
+7K172685LiverMultiScanPerspectum Diagnostics, Ltd.20177—
+7K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc.201730Class I
+7K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+7K163312MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 SoftwareSiemens Medical Solutions USA, Inc.20174—
+7K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+7K151353syngo.MR Neurology, syngo.MR OncologySiemens Medical Solutions USA, Inc.201525—
+7K142098Signa Pet/MRGe Medical Systems, LLC201466
+7K140897Syngo.MR Neurology, Syngo.MMR GeneralSiemens Medical Solutions USA, Inc.20140—
+8K252571mdprostateMediaire GmbH20260—
+8K253690LungMapsSiemens Healthineers AG20260—
+8K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+8K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+8K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+8K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+8K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+8K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+8K232322MAGNETOM Terra; MAGNETOM Terra.XSiemens Medical Solutions USA, Inc.20240—
+8K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+8K231617MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.20232—
+8K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+8K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+8K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+8K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+8K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+8K201540uMR570Shanghai United Imaging Healthcare Co., Ltd.20205—
+8K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+8K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+8K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+8K193176uMR 780Shanghai United Imaging Healthcare Co., Ltd.20200—
+8K193200uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20208—
+8K192496Magnetom Sola, Magnetom Altea and Magnetom Sola FitSiemens Medical Solutions USA, Inc.20200—
+8K190017LiverMultiScan (LMSv3)Perspectum Diagnostics, Ltd.20196—
+8K190757MAGNETOM Avanto FitSiemens Medical Solution USA, Inc.20190—
+8K183014uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20193—
+8K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+8K182299MAGNETOM AeraSiemens Medical Solutions USA, Inc.20181—
+8K181433MAGNETOM VidaSiemens Medical Solutions USA, Inc.201828—
+8K173617MAGNETOM Vida with Compressed Sensing GRASP-VIBESiemens Medical Solutions USA, Inc.20180—
+8K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+8K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+8K163619Signa Pet/MRGe Medical Systems, LLC201717
+9K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+9K251822MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance, Ltd.20251—
+9K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+9K241211CoLumboSmart Soft Healthcare20242—
+9K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+9K230758uMR 570Shanghai United Imaging Healthcare Co., Ltd.20230—
+9K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+9K222755uMR 680Shanghai United Imaging Intelligence Co., Ltd.20233—
+9K220332uMR Omega with uWS-MR-MRSShanghai United Imaging Healthcare Co., Ltd.20227—
+9K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+9K220497CoLumboSmart Soft Healthcare AD20226—
+9K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+9K213709Signa Pet/MRGe Medical Systems, LLC202203
+9K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+9K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+9K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+9K202170LiverMultiScanPerspectum, Ltd.20203—
+9K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+9K200899Quantib AI NodeQuantib B.V.20200—
+9K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20192—
+9K190138MAGNETOM AeraSiemens Medical Solutions USA, Inc.20190—
+9K183244MAGNETOM LuminaSiemens Medical Solutions USA, Inc.20190Class I
+9K183254Magnetom VidaSiemens Medical Solutions USA, Inc.201926—
+10K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+10K260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance, Ltd.20260—
+10K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+10K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+10K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+10K250367CoLumboXSmart Soft Healthcare AD20250—