510(k) Report

Devices descending from K040665

136 later devices reach Somatom Sensation 64 and Sensation Cardiac through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTSiemens Medical Solutions USA, Inc.20160—
+9K253574SOMATOM X.cite; SOMATOM X.ceedSiemens Medical Solutions USA, Inc.20260—
+9K251671Biograph Vision PET/CT Systems; Biograph mCT PET/CT SystemsSiemens Medical Solutions USA, Inc.20250—
+9K250822SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM…Siemens Medical Solutions USA, Inc.20251—
+9K241079uCT 780Shanghai United Imaging Healthcare Co., Ltd.202512
+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—
+9K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+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—
+10K253173uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202601
+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
+10K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+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—
+11K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+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—
+12K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—