510(k) Report

Devices descending from K010641

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K123230Mosaiq Oncology Information SystemImpac Medical Systems, Inc.2012207
+8K113620Myrian 1.11Intrasense20126—
+8K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+8K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+8K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+9K260597Virtue QAProNova Solutions20260—
+9K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+9K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+9K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+9K251883MIM – LesionID ProMim Software, Inc.20250—
+9K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+9K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+9K250039HPACSHealthhub20250—
+9K242919V5med Lung AIV5med, Inc.20250—
+9K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+9K241364Hybrid Viewer (00859873006189)Hermes Medical Solutions AB20241—
+9K232479ART-PlanTherapanacea20232—
+9K231420Aura 10 PET/CTXeos Medical20230—
+9K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+9K230575Limbus ContourLimbus Ai, Inc.20231—
+9K223774Contour ProtégéAIMim Software, Inc.20233—
+9K221612ClearRead CTRiverain Technologies, Inc.20220—
+9K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+9K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+9K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+9K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+9K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+9K212915MVision AI SegmentationMVision AI20221—
+9K220590aPROMISE XExini Diagnostics AB20220—
+9K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+9K210831OnQ NeuroCortechs Labs, Inc.20213—
+9K212887RTappSegana, Inc.20210—
+9K212896Visible Patient SuiteVisible Patient, Sas20213—
+9K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+9K211764Vereos PET/CTPhilips Medical Systems Nederland B.V.20210—
+9K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+9K202928DV. TargetDeepvoxel, Inc.20210—
+9K203235VBrainVysioneer, Inc.20214—
+9K201103Xeleris V Processing and Review SystemsGE Healthcare20204—
+9K200822BraidBraid.Health20201—
+9K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+9K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+9K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+9K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+9K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+9K192424Mobius3DVarian Medical Systems, Inc.20194—
+9K190694Unifi Workspace v1.0.0Hologic, Inc.20192—
+9K190232Synapse PACSFujifilm Corporation2019311
+9K181646Celesteion, PCA-9000A/3, V6.5Canon Medical Systems Corporation20180—
+9K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+9K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+9K182034Arterys MICAArterys, Inc.20183—
+9K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+9K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+9K173475Merge PACSMerge Healthcare Incorporated201712
+9K171719Hybrid3DHermes Medical Solutions AB20175—
+9K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+9K163668SuitestensaEbit Srl20170—
+9K163394Hybrid3DHermes Medical Solutions AB20176—
+9K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+9K161130ResolutionMDCalgary Scientific, Inc.20164—
+9K150843syngo®.via (version VB10A)Siemens AG201546—
+9K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+9K142142Quality ReportsSun Nuclear Corporation20145—
+9K141572Mosaiq Oncology Information SystemImpac Medical Systems, Inc.20141311
+9K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+9K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+9K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+10K260500ResolutionMDResolutionMD, Inc.20260—
+10K253078ART.1-USSeetreat Pty, Ltd.20260—
+10K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+10K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+10K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+10K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202611
+10K252922Neosoma Brain MetsNeosoma, Inc.20250—
+10K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+10K252477Hybrid Viewer (00859873006240)Hermes Medical Solutions AB20250—
+10K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+10K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+10K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+10K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+10K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+10K250416GBrain MRIGalileo Cds, Inc.20251—
+10K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+10K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+10K241837Limbus ContourLimbus Ai, Inc.20240—
+10K233457RUSHutom, Inc.20240—
+10K233908cNeuro cDATCombinostics OY20240—
+10K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+10K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+10K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+10K231765Contour ProtégéAIMim Software, Inc.20232—
+10K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+10K231185MapRTVision Rt, Ltd.20231—
+10K230082Auto SegmentationGe Medical Systems, LLC20231—
+10K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+10K221984InterView XP; InterView FUSIONMediso Medical Imaging Systems, Lttd.20230—
+10K221706AccuContourManteia Technologies Co., Ltd.20232—
+10K221680Xeleris V Processing and Review SystemGE Healthcare20231—
+10K220630TorchTM SoftwareVoximetry, Incorporated20221—