510(k) Report

Devices descending from K023518

71 later devices reach Ecat Lso Pet/CT 16 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033431Lso Pet/CT Hirez and Lso Pet/CT 16 HirezCti Pet Systems, Inc.2003681
+1K023768Ecat Pet/CT; Ecat Lso Pet/CT; Ecat Lso Pet/CT 16Cti Pet Systems, Inc.20021—
+2K050509Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc.200566—
+2K042467Lso Pet/CT Hirez 64Cti Pet Systems, Inc.2004671
+2K042428SCEPTREP3 Pet/CTHitachi Medical Systems America, Inc.200402
+3K060631Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc.2006643
+3K060060Biograph 6Siemens Medical Solutions USA, Inc.200665—
+4K173547ImagenUniversalCardiovascular Imaging Technologies20180—
+4K083852Biograph 16 True Point SystemsSiemens Medical Solutions USA, Inc.20090—
+4K081453Biograph HD FamilySiemens Medical Solutions USA, Inc.200862—
+4K071068Biograph 6 Truepoint, Model Biograph 6 - P/N 10238197Siemens Medical Solutions USA, Inc.20070—
+5K103429Biograph MMRSiemens Medical Solutions USA, Inc.2011211
+5K101550Biograph MCT FamilySiemens Medical Solutions USA, Inc.201038—
+6K133226Biograph MMRSiemens Medical Solutions USA, Inc.2013201
+6K113448Biograph MCT FamilySiemens Medical Solutions USA, Inc.201137—
+7K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc.201712—
+7K142098Signa Pet/MRGe Medical Systems, LLC201466
+7K123737Biograph MCT FamilySiemens Medical Solutions USA, Inc.20133617
+8K253963Cubresa BrainPETCubresa, Inc.20260—
+8K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.20201Class I
+8K183014uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20193—
+8K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+8K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.20170—
+8K163619Signa Pet/MRGe Medical Systems, LLC201717
+8K151486Biograph mCT and mCT Flow PET/CT ScannersSiemens Medical Solutions USA, Inc.20153411
+8K141971Biograph True Pet/CT Family SoftwareSiemens Medical Solutions USA, Inc.2014037
+9K253023BIOGRAPH OneSiemens Healthineers AG20260—
+9K213709Signa Pet/MRGe Medical Systems, LLC202203
+9K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20192—
+9K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+9K172143uMI 780 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd.2018162
+9K173578Biograph mCT Family of PET/CT SystemsSiemens Medical Solutions USA, Inc.201792
+9K152880Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc.201651
+10K241596uMI PanvivoShanghai United Imaging Healthcare Co., Ltd.202451
+10K223325uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202332
+10K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20221—
+10K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+10K193210Hyper DLRShanghai United Imaging Healthcare Co., Ltd.20200—
+10K193248Biograph Vision, Biograph mCT Family of PET/CTsSiemens Medical Solutions USA, Inc.202062
+10K182938Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd.201811
+10K182237uMI 550 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd.2018310
+10K180811Biograph VisionSiemens Medical Solutions USA, Inc.20188—
+10K170904Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc.201734
+10K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTSiemens Medical Solutions USA, Inc.20160—
+11K251671Biograph Vision PET/CT Systems; Biograph mCT PET/CT SystemsSiemens Medical Solutions USA, Inc.20250—
+11K243538uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd.202441
+11K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20240—
+11K231762uEXPLORERShanghai United Imaging Healthcare Co., Ltd.202401
+11K233677Biograph VK10Siemens Medical Solutions USA, Inc.20241—
+11K232712uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202302
+11K231572uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202311
+11K231833Biograph Vision.X and Biograph Vision.X EdgeSiemens Medical Solutions USA, Inc.20230—
+11K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+11K210262Biograph Vision Quadra PET/CT SystemSiemens Medical Solutions USA, Inc.20211—
+11K193178Biograph HorizonSiemens Medical Solution USA, Inc.202021
+11K193241Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd.202016
+11K190900Biograph VisionSiemens Medical Solutions USA, Inc.20197—
+12K253844AnyScan 3.0 NM Scanner FamilyMediso Medical Imaging Systems, Ltd.20250—
+12K251561Biograph TrinionSiemens Medical Solutions USA, Inc.20250—
+12K251839uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd.202532
+12K241585uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202401
+12K223547Biograph Vision Quadra PET/CT SystemSiemens Medical Solutions USA, Inc.20220—
+12K222895DynamicIQGE Medical Systems SCS20220—
+12K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+12K210001HYPER AiRShanghai United Imaging Healthcare Co., Ltd.20210—
+13K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd.20260—
+13K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…Shanghai United Imaging Healthcare Co., Ltd.20261—
+13K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+14K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+14K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…Shanghai United Imaging Healthcare Co., Ltd.20260—
+14K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—