510(k) Report

Devices descending from K982349

143 later devices reach Somatom Plus 4WITH Volume Zoom CT Scanners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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
+10K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+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—
+11K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+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
+12K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+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—
+13K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+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—
+14K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—