510(k) Report

Devices descending from K033431

68 later devices reach Lso Pet/CT Hirez and Lso Pet/CT 16 Hirez through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050509Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc.200566—
+1K042467Lso Pet/CT Hirez 64Cti Pet Systems, Inc.2004671
+2K060631Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc.2006643
+2K060060Biograph 6Siemens Medical Solutions USA, Inc.200665—
+3K173547ImagenUniversalCardiovascular Imaging Technologies20180—
+3K083852Biograph 16 True Point SystemsSiemens Medical Solutions USA, Inc.20090—
+3K081453Biograph HD FamilySiemens Medical Solutions USA, Inc.200862—
+3K071068Biograph 6 Truepoint, Model Biograph 6 - P/N 10238197Siemens Medical Solutions USA, Inc.20070—
+4K103429Biograph MMRSiemens Medical Solutions USA, Inc.2011211
+4K101550Biograph MCT FamilySiemens Medical Solutions USA, Inc.201038—
+5K133226Biograph MMRSiemens Medical Solutions USA, Inc.2013201
+5K113448Biograph MCT FamilySiemens Medical Solutions USA, Inc.201137—
+6K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc.201712—
+6K142098Signa Pet/MRGe Medical Systems, LLC201466
+6K123737Biograph MCT FamilySiemens Medical Solutions USA, Inc.20133617
+7K253963Cubresa BrainPETCubresa, Inc.20260—
+7K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.20201Class I
+7K183014uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20193—
+7K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+7K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.20170—
+7K163619Signa Pet/MRGe Medical Systems, LLC201717
+7K151486Biograph mCT and mCT Flow PET/CT ScannersSiemens Medical Solutions USA, Inc.20153411
+7K141971Biograph True Pet/CT Family SoftwareSiemens Medical Solutions USA, Inc.2014037
+8K253023BIOGRAPH OneSiemens Healthineers AG20260—
+8K213709Signa Pet/MRGe Medical Systems, LLC202203
+8K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20192—
+8K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+8K172143uMI 780 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd.2018162
+8K173578Biograph mCT Family of PET/CT SystemsSiemens Medical Solutions USA, Inc.201792
+8K152880Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc.201651
+9K241596uMI PanvivoShanghai United Imaging Healthcare Co., Ltd.202451
+9K223325uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202332
+9K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20221—
+9K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+9K193210Hyper DLRShanghai United Imaging Healthcare Co., Ltd.20200—
+9K193248Biograph Vision, Biograph mCT Family of PET/CTsSiemens Medical Solutions USA, Inc.202062
+9K182938Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd.201811
+9K182237uMI 550 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd.2018310
+9K180811Biograph VisionSiemens Medical Solutions USA, Inc.20188—
+9K170904Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc.201734
+9K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTSiemens Medical Solutions USA, Inc.20160—
+10K251671Biograph Vision PET/CT Systems; Biograph mCT PET/CT SystemsSiemens Medical Solutions USA, Inc.20250—
+10K243538uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd.202441
+10K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20240—
+10K231762uEXPLORERShanghai United Imaging Healthcare Co., Ltd.202401
+10K233677Biograph VK10Siemens Medical Solutions USA, Inc.20241—
+10K232712uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202302
+10K231572uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202311
+10K231833Biograph Vision.X and Biograph Vision.X EdgeSiemens Medical Solutions USA, Inc.20230—
+10K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+10K210262Biograph Vision Quadra PET/CT SystemSiemens Medical Solutions USA, Inc.20211—
+10K193178Biograph HorizonSiemens Medical Solution USA, Inc.202021
+10K193241Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd.202016
+10K190900Biograph VisionSiemens Medical Solutions USA, Inc.20197—
+11K253844AnyScan 3.0 NM Scanner FamilyMediso Medical Imaging Systems, Ltd.20250—
+11K251561Biograph TrinionSiemens Medical Solutions USA, Inc.20250—
+11K251839uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd.202532
+11K241585uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202401
+11K223547Biograph Vision Quadra PET/CT SystemSiemens Medical Solutions USA, Inc.20220—
+11K222895DynamicIQGE Medical Systems SCS20220—
+11K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+11K210001HYPER AiRShanghai United Imaging Healthcare Co., Ltd.20210—
+12K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd.20260—
+12K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…Shanghai United Imaging Healthcare Co., Ltd.20261—
+12K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+13K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+13K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…Shanghai United Imaging Healthcare Co., Ltd.20260—
+13K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—