510(k) Report

Devices descending from K002715

271 later devices reach Ecat Pet Scanner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20192—
+10K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+10K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+10K172143uMI 780 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd.2018162
+10K173578Biograph mCT Family of PET/CT SystemsSiemens Medical Solutions USA, Inc.201792
+10K152880Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc.201651
+11K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+11K243186Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7…Siemens Medical Solutions USA, Inc.20241—
+11K241596uMI PanvivoShanghai United Imaging Healthcare Co., Ltd.202451
+11K223325uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202332
+11K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20221—
+11K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+11K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+11K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+11K193210Hyper DLRShanghai United Imaging Healthcare Co., Ltd.20200—
+11K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+11K193248Biograph Vision, Biograph mCT Family of PET/CTsSiemens Medical Solutions USA, Inc.202062
+11K182938Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd.201811
+11K182237uMI 550 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd.2018310
+11K180811Biograph VisionSiemens Medical Solutions USA, Inc.20188—
+11K170904Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc.201734
+11K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTSiemens Medical Solutions USA, Inc.20160—
+12K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7…Siemens Medical Solutions USA, Inc.20260—
+12K251671Biograph Vision PET/CT Systems; Biograph mCT PET/CT SystemsSiemens Medical Solutions USA, Inc.20250—
+12K243538uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd.202441
+12K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+12K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20240—
+12K231762uEXPLORERShanghai United Imaging Healthcare Co., Ltd.202401
+12K233677Biograph VK10Siemens Medical Solutions USA, Inc.20241—
+12K232712uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202302
+12K231572uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202311
+12K231833Biograph Vision.X and Biograph Vision.X EdgeSiemens Medical Solutions USA, Inc.20230—
+12K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+12K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+12K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+12K210262Biograph Vision Quadra PET/CT SystemSiemens Medical Solutions USA, Inc.20211—
+12K193178Biograph HorizonSiemens Medical Solution USA, Inc.202021
+12K193241Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd.202016
+12K190900Biograph VisionSiemens Medical Solutions USA, Inc.20197—
+13K251561Biograph TrinionSiemens Medical Solutions USA, Inc.20250—
+13K251839uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd.202532
+13K241585uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202401
+13K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+13K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+13K223547Biograph Vision Quadra PET/CT SystemSiemens Medical Solutions USA, Inc.20220—
+13K222895DynamicIQGE Medical Systems SCS20220—
+13K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+13K210001HYPER AiRShanghai United Imaging Healthcare Co., Ltd.20210—
+14K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd.20260—
+14K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…Shanghai United Imaging Healthcare Co., Ltd.20261—
+14K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+14K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+14K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+14K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+15K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+15K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…Shanghai United Imaging Healthcare Co., Ltd.20260—
+15K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+15K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+15K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+15K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+15K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+15K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+15K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+16K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+16K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+16K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+16K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+17K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+17K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+17K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+18K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—