510(k) Report

Devices descending from K060060

65 later devices reach Biograph 6 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071068Biograph 6 Truepoint, Model Biograph 6 - P/N 10238197Siemens Medical Solutions USA, Inc.20070—
+1K060631Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc.2006643
+2K173547ImagenUniversalCardiovascular Imaging Technologies20180—
+2K083852Biograph 16 True Point SystemsSiemens Medical Solutions USA, Inc.20090—
+2K081453Biograph HD FamilySiemens Medical Solutions USA, Inc.200862—
+3K103429Biograph MMRSiemens Medical Solutions USA, Inc.2011211
+3K101550Biograph MCT FamilySiemens Medical Solutions USA, Inc.201038—
+4K133226Biograph MMRSiemens Medical Solutions USA, Inc.2013201
+4K113448Biograph MCT FamilySiemens Medical Solutions USA, Inc.201137—
+5K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc.201712—
+5K142098Signa Pet/MRGe Medical Systems, LLC201466
+5K123737Biograph MCT FamilySiemens Medical Solutions USA, Inc.20133617
+6K253963Cubresa BrainPETCubresa, Inc.20260—
+6K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.20201Class I
+6K183014uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20193—
+6K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+6K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.20170—
+6K163619Signa Pet/MRGe Medical Systems, LLC201717
+6K151486Biograph mCT and mCT Flow PET/CT ScannersSiemens Medical Solutions USA, Inc.20153411
+6K141971Biograph True Pet/CT Family SoftwareSiemens Medical Solutions USA, Inc.2014037
+7K253023BIOGRAPH OneSiemens Healthineers AG20260—
+7K213709Signa Pet/MRGe Medical Systems, LLC202203
+7K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20192—
+7K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+7K172143uMI 780 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd.2018162
+7K173578Biograph mCT Family of PET/CT SystemsSiemens Medical Solutions USA, Inc.201792
+7K152880Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc.201651
+8K241596uMI PanvivoShanghai United Imaging Healthcare Co., Ltd.202451
+8K223325uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202332
+8K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20221—
+8K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+8K193210Hyper DLRShanghai United Imaging Healthcare Co., Ltd.20200—
+8K193248Biograph Vision, Biograph mCT Family of PET/CTsSiemens Medical Solutions USA, Inc.202062
+8K182938Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd.201811
+8K182237uMI 550 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd.2018310
+8K180811Biograph VisionSiemens Medical Solutions USA, Inc.20188—
+8K170904Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc.201734
+8K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTSiemens Medical Solutions USA, Inc.20160—
+9K251671Biograph Vision PET/CT Systems; Biograph mCT PET/CT SystemsSiemens Medical Solutions USA, Inc.20250—
+9K243538uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd.202441
+9K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20240—
+9K231762uEXPLORERShanghai United Imaging Healthcare Co., Ltd.202401
+9K233677Biograph VK10Siemens Medical Solutions USA, Inc.20241—
+9K232712uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202302
+9K231572uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202311
+9K231833Biograph Vision.X and Biograph Vision.X EdgeSiemens Medical Solutions USA, Inc.20230—
+9K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+9K210262Biograph Vision Quadra PET/CT SystemSiemens Medical Solutions USA, Inc.20211—
+9K193178Biograph HorizonSiemens Medical Solution USA, Inc.202021
+9K193241Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd.202016
+9K190900Biograph VisionSiemens Medical Solutions USA, Inc.20197—
+10K253844AnyScan 3.0 NM Scanner FamilyMediso Medical Imaging Systems, Ltd.20250—
+10K251561Biograph TrinionSiemens Medical Solutions USA, Inc.20250—
+10K251839uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd.202532
+10K241585uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202401
+10K223547Biograph Vision Quadra PET/CT SystemSiemens Medical Solutions USA, Inc.20220—
+10K222895DynamicIQGE Medical Systems SCS20220—
+10K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+10K210001HYPER AiRShanghai United Imaging Healthcare Co., Ltd.20210—
+11K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd.20260—
+11K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…Shanghai United Imaging Healthcare Co., Ltd.20261—
+11K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+12K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+12K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…Shanghai United Imaging Healthcare Co., Ltd.20260—
+12K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—