510(k) Report

Devices descending from K123938

38 later devices reach Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree, Syngo MR… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231133neo315Neoscan Solution GmbH20240—
+1K170840MAGNETOM TerraSiemens Medical Solutions USA, Inc.20172—
+1K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc.201312Class I
+1K133226Biograph MMRSiemens Medical Solutions USA, Inc.2013201
+2K183222MAGNETOM TerraSiemens Medical Solutions USA, Inc.20191—
+2K181371uMR 790Shanghai United Imaging Healthcare Co., Ltd.201811—
+2K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc.201712—
+2K142098Signa Pet/MRGe Medical Systems, LLC201466
+3K253963Cubresa BrainPETCubresa, Inc.20260—
+3K232322MAGNETOM Terra; MAGNETOM Terra.XSiemens Medical Solutions USA, Inc.20240—
+3K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.20201Class I
+3K191157uMR 780, uMR 790Shanghai United Imaging Healthcare Co., Ltd.201910—
+3K183014uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20193—
+3K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+3K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.20170—
+3K163619Signa Pet/MRGe Medical Systems, LLC201717
+4K253023BIOGRAPH OneSiemens Healthineers AG20260—
+4K213709Signa Pet/MRGe Medical Systems, LLC202203
+4K193176uMR 780Shanghai United Imaging Healthcare Co., Ltd.20200—
+4K193200uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20208—
+4K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20192—
+4K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+5K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20221—
+5K220332uMR Omega with uWS-MR-MRSShanghai United Imaging Healthcare Co., Ltd.20227—
+5K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+6K243122uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20252—
+6K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20240—
+6K230152uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20236—
+6K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+7K243547uMR UltraShanghai United Imaging Healthcare Co., Ltd.20251—
+7K233673uMR JupiterShanghai United Imaging Healthcare Co., Ltd.20241—
+7K240540uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20243—
+7K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+8K260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.20260—
+8K250246uMR JupiterShanghai United Imaging Healthcare Co., Ltd.20250—
+8K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+9K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+9K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—