510(k) Report

Devices descending from K010641

493 later devices reach GE CT-Pet System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K211760Panther OISProwess, Inc.20210—
+12K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+12K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+12K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+12K202229AI MetricsAi Metrics, LLC20200—
+12K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+12K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+12K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+12K200899Quantib AI NodeQuantib B.V.20200—
+12K200487RayCare 3.1RaySearch Laboratories AB (PUBL)202015
+12K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+12K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+12K190178Monaco RTP SystemElekta, Inc.201945
+12K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+12K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+13K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+13K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+13K252571mdprostateMediaire GmbH20260—
+13K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+13K253690LungMapsSiemens Healthineers AG20260—
+13K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+13K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+13K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+13K242992RayCare (2024A SP1)RaySearch Laboratories AB (PUBL)202502
+13K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+13K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+13K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+13K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+13K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+13K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+13K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+13K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+13K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+13K211867RayStation 11.0RaySearch Laboratories AB (PUBL)202148
+13K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+13K202789Monaco Rtp SystemElekta Solutions AB20213—
+13K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+13K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+14K261306AI Contouring (VA10A)Varian Medical Systems20260—
+14K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+14K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+14K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+14K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+14K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+14K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+14K241211CoLumboSmart Soft Healthcare20242—
+14K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+14K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+14K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+14K220497CoLumboSmart Soft Healthcare AD20226—
+14K213787Monaco RTP SystemElekta Solutions AB20222—
+14K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+14K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+14K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+15K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+15K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+15K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+15K250367CoLumboXSmart Soft Healthcare AD20250—
+15K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+15K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+15K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+15K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+15K240793MSKaiMskai20240—
+15K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+15K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+15K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+15K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+15K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+15K223233Monaco RTP SystemElekta Solutions AB20231—
+15K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+16K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+16K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+16K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+16K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+16K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+16K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+16K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+16K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+16K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+16K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+16K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+17K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+17K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+17K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—
+17K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+17K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+17K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+17K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+18K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+18K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+18K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+19K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+20K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—