510(k) Report

Devices descending from K081453

62 later devices reach Biograph HD Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103429Biograph MMRSiemens Medical Solutions USA, Inc.2011211
+1K101550Biograph MCT FamilySiemens Medical Solutions USA, Inc.201038—
+1K083852Biograph 16 True Point SystemsSiemens Medical Solutions USA, Inc.20090—
+2K133226Biograph MMRSiemens Medical Solutions USA, Inc.2013201
+2K113448Biograph MCT FamilySiemens Medical Solutions USA, Inc.201137—
+3K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc.201712—
+3K142098Signa Pet/MRGe Medical Systems, LLC201466
+3K123737Biograph MCT FamilySiemens Medical Solutions USA, Inc.20133617
+4K253963Cubresa BrainPETCubresa, Inc.20260—
+4K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.20201Class I
+4K183014uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20193—
+4K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+4K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.20170—
+4K163619Signa Pet/MRGe Medical Systems, LLC201717
+4K151486Biograph mCT and mCT Flow PET/CT ScannersSiemens Medical Solutions USA, Inc.20153411
+4K141971Biograph True Pet/CT Family SoftwareSiemens Medical Solutions USA, Inc.2014037
+5K253023BIOGRAPH OneSiemens Healthineers AG20260—
+5K213709Signa Pet/MRGe Medical Systems, LLC202203
+5K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20192—
+5K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+5K172143uMI 780 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd.2018162
+5K173547ImagenUniversalCardiovascular Imaging Technologies20180—
+5K173578Biograph mCT Family of PET/CT SystemsSiemens Medical Solutions USA, Inc.201792
+5K152880Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc.201651
+6K241596uMI PanvivoShanghai United Imaging Healthcare Co., Ltd.202451
+6K223325uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202332
+6K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20221—
+6K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+6K193210Hyper DLRShanghai United Imaging Healthcare Co., Ltd.20200—
+6K193248Biograph Vision, Biograph mCT Family of PET/CTsSiemens Medical Solutions USA, Inc.202062
+6K182938Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd.201811
+6K182237uMI 550 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd.2018310
+6K180811Biograph VisionSiemens Medical Solutions USA, Inc.20188—
+6K170904Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc.201734
+6K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTSiemens Medical Solutions USA, Inc.20160—
+7K251671Biograph Vision PET/CT Systems; Biograph mCT PET/CT SystemsSiemens Medical Solutions USA, Inc.20250—
+7K243538uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd.202441
+7K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20240—
+7K231762uEXPLORERShanghai United Imaging Healthcare Co., Ltd.202401
+7K233677Biograph VK10Siemens Medical Solutions USA, Inc.20241—
+7K232712uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202302
+7K231572uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202311
+7K231833Biograph Vision.X and Biograph Vision.X EdgeSiemens Medical Solutions USA, Inc.20230—
+7K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+7K210262Biograph Vision Quadra PET/CT SystemSiemens Medical Solutions USA, Inc.20211—
+7K193178Biograph HorizonSiemens Medical Solution USA, Inc.202021
+7K193241Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd.202016
+7K190900Biograph VisionSiemens Medical Solutions USA, Inc.20197—
+8K253844AnyScan 3.0 NM Scanner FamilyMediso Medical Imaging Systems, Ltd.20250—
+8K251561Biograph TrinionSiemens Medical Solutions USA, Inc.20250—
+8K251839uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd.202532
+8K241585uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202401
+8K223547Biograph Vision Quadra PET/CT SystemSiemens Medical Solutions USA, Inc.20220—
+8K222895DynamicIQGE Medical Systems SCS20220—
+8K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+8K210001HYPER AiRShanghai United Imaging Healthcare Co., Ltd.20210—
+9K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd.20260—
+9K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…Shanghai United Imaging Healthcare Co., Ltd.20261—
+9K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+10K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+10K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…Shanghai United Imaging Healthcare Co., Ltd.20260—
+10K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—