510(k) Report

Devices descending from K100113

227 later devices reach Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+6K252571mdprostateMediaire GmbH20260—
+6K253690LungMapsSiemens Healthineers AG20260—
+6K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+6K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+6K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+6K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+6K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+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—
+6K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+6K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+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—
+6K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+6K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+6K193176uMR 780Shanghai United Imaging Healthcare Co., Ltd.20200—
+6K193200uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20208—
+6K192496Magnetom Sola, Magnetom Altea and Magnetom Sola FitSiemens Medical Solutions USA, Inc.20200—
+6K190017LiverMultiScan (LMSv3)Perspectum Diagnostics, Ltd.20196—
+6K190757MAGNETOM Avanto FitSiemens Medical Solution USA, Inc.20190—
+6K183014uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20193—
+6K183221MAGNETOM Amira, MAGNETOM SempraSiemens Medical Solutions USA, Inc.201961
+6K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+6K182299MAGNETOM AeraSiemens Medical Solutions USA, Inc.20181—
+6K181433MAGNETOM VidaSiemens Medical Solutions USA, Inc.201828—
+6K173617MAGNETOM Vida with Compressed Sensing GRASP-VIBESiemens Medical Solutions USA, Inc.20180—
+6K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+6K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+6K163619Signa Pet/MRGe Medical Systems, LLC201717
+7K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+7K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+7K241211CoLumboSmart Soft Healthcare20242—
+7K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+7K230758uMR 570Shanghai United Imaging Healthcare Co., Ltd.20230—
+7K223343MAGNETOM Amira; MAGNETOM SempraSiemens Medical Solutions USA, Inc.202301
+7K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+7K222755uMR 680Shanghai United Imaging Intelligence Co., Ltd.20233—
+7K220332uMR Omega with uWS-MR-MRSShanghai United Imaging Healthcare Co., Ltd.20227—
+7K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+7K220497CoLumboSmart Soft Healthcare AD20226—
+7K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+7K213709Signa Pet/MRGe Medical Systems, LLC202203
+7K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+7K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+7K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+7K210611MAGNETOM Free.MaxSiemens Medical Solutions USA, Inc.202141
+7K202170LiverMultiScanPerspectum, Ltd.20203—
+7K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+7K200899Quantib AI NodeQuantib B.V.20200—
+7K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20192—
+7K190138MAGNETOM AeraSiemens Medical Solutions USA, Inc.20190—
+7K183244MAGNETOM LuminaSiemens Medical Solutions USA, Inc.20190Class I
+7K183254Magnetom VidaSiemens Medical Solutions USA, Inc.201926—
+8K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+8K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+8K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+8K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+8K250367CoLumboXSmart Soft Healthcare AD20250—
+8K243122uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20252—
+8K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+8K240793MSKaiMskai20240—
+8K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+8K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+8K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+8K240744uMR 680Shanghai United Imaging Healthcare Co., Ltd.20242—
+8K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+8K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+8K230152uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20236—
+8K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+8K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20221—
+8K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+8K213960LiverMultiScan v5 (LMSv5)Perspectum20221—
+8K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+8K220575MAGNETOM Free.Max, MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.202231
+8K203280Hepatica v1 (Hepatica v1.0.0)Perspectum, Ltd.20210—
+8K192924MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitSiemens Medical Solutions USA, Inc.202022Class I
+8K193324Motion Correction SystemKineticor, Inc.20202—
+9K253413LiverMultiScan (v6.0)Perspectum, Ltd.20260—
+9K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+9K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+9K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+9K243547uMR UltraShanghai United Imaging Healthcare Co., Ltd.20251—
+9K243397uMR 680Shanghai United Imaging Healthcare Co., Ltd.20251—
+9K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20240—
+9K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+9K233673uMR JupiterShanghai United Imaging Healthcare Co., Ltd.20241—
+9K240540uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20243—
+9K231617MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.20232—
+9K213805MAGNETOM VidaSiemens Medical Solutions USA, Inc.20230—