510(k) Report

Devices descending from K113448

37 later devices reach Biograph MCT Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123737Biograph MCT FamilySiemens Medical Solutions USA, Inc.20133617
+2K151486Biograph mCT and mCT Flow PET/CT ScannersSiemens Medical Solutions USA, Inc.20153411
+2K141971Biograph True Pet/CT Family SoftwareSiemens Medical Solutions USA, Inc.2014037
+3K172143uMI 780 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd.2018162
+3K173547ImagenUniversalCardiovascular Imaging Technologies20180—
+3K173578Biograph mCT Family of PET/CT SystemsSiemens Medical Solutions USA, Inc.201792
+3K152880Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc.201651
+4K241596uMI PanvivoShanghai United Imaging Healthcare Co., Ltd.202451
+4K223325uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202332
+4K193210Hyper DLRShanghai United Imaging Healthcare Co., Ltd.20200—
+4K193248Biograph Vision, Biograph mCT Family of PET/CTsSiemens Medical Solutions USA, Inc.202062
+4K182938Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd.201811
+4K182237uMI 550 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd.2018310
+4K180811Biograph VisionSiemens Medical Solutions USA, Inc.20188—
+4K170904Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc.201734
+4K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTSiemens Medical Solutions USA, Inc.20160—
+5K251671Biograph Vision PET/CT Systems; Biograph mCT PET/CT SystemsSiemens Medical Solutions USA, Inc.20250—
+5K243538uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd.202441
+5K231762uEXPLORERShanghai United Imaging Healthcare Co., Ltd.202401
+5K233677Biograph VK10Siemens Medical Solutions USA, Inc.20241—
+5K232712uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202302
+5K231572uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202311
+5K231833Biograph Vision.X and Biograph Vision.X EdgeSiemens Medical Solutions USA, Inc.20230—
+5K210262Biograph Vision Quadra PET/CT SystemSiemens Medical Solutions USA, Inc.20211—
+5K193178Biograph HorizonSiemens Medical Solution USA, Inc.202021
+5K193241Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd.202016
+5K190900Biograph VisionSiemens Medical Solutions USA, Inc.20197—
+6K253844AnyScan 3.0 NM Scanner FamilyMediso Medical Imaging Systems, Ltd.20250—
+6K251561Biograph TrinionSiemens Medical Solutions USA, Inc.20250—
+6K251839uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd.202532
+6K241585uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202401
+6K223547Biograph Vision Quadra PET/CT SystemSiemens Medical Solutions USA, Inc.20220—
+6K222895DynamicIQGE Medical Systems SCS20220—
+6K210001HYPER AiRShanghai United Imaging Healthcare Co., Ltd.20210—
+7K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd.20260—
+7K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…Shanghai United Imaging Healthcare Co., Ltd.20261—
+8K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…Shanghai United Imaging Healthcare Co., Ltd.20260—