510(k) Report

Devices descending from K010641

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042257Discovery ST Pet/CT Imaging System with an Alternate Detector OptionGeneral Electric Co.2004141
+1K023988GE Discovery LS SystemGE Medical Systems20034661
+1K022872GE Road Warrior Pet CT Imaging SystemGeneral Electric Co.2002398—
+1K013521Gemini Imaging SystemAdac Laboratories2001882
+2K050366ImagenproCardiovascular Imaging Technologies, LLC20051—
+2K050559GE Discovery VCT SystemGE Medical Systems2005131
+2K041543GE Discovery STGE Healthcare20043961
+2K040172Modification to GE Discovery LS SystemGE Medical Systems20044635
+2K032036Gemini 16Philips Medical Systems (Cleveland), Inc.2003872
+2K030199GE Mobile Discovery ST Pet CT Imaging SystemGeneral Electric Co.20030—
+3K173547ImagenUniversalCardiovascular Imaging Technologies20180—
+3K151403Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron…Neusoft Medical Systems Co., Ltd.20150—
+3K113086ACQATexas Medical Imaging Consultants20120—
+3K103710WBR Xpress PetUltraspect, Ltd.20110—
+3K082244Pca-8000A, Mark 11, Pet / CT SystemToshiba America Medical Systems, In.C20080—
+3K081496Optima Pet/CT 560Ge Medical Systems, LLC2008107
+3K042863SceniumSiemens Molecular Imaging, Ltd.2004380—
+3K041955Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc.2004652
+3K041220GE Discovery ST SystemGE Medical Systems20040—
+3K041182SyntegraAdac Laboratories200420—
+4K133657Discovery Pet/CT 710Ge Medical Systems, LLC201474
+4K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+4K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+4K113408Q. Freeze (Motion VUE2)Ge Medical Systems, LLC20121—
+4K081987Unisyn Image Fusion, Version 1.0Convergent Imaging Solutions20087—
+4K062650EP Navigator SoftwarePhilips Medical Systems200649—
+4K062393GE Vantage Pet Neuro SoftwareGE Healthcare20063—
+4K061545Scenium 1.1Siemens Molecular Imaging, Ltd.200691—
+4K061671Syngo Trued, Model VC10ASiemens Medical Solutions200611—
+4K060816Mim 4.0 (NeuroMimvista Corp.20063501
+4K042935Gemini GXLPhilips Medical Systems (Cleveland), Inc.2004142
+5K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+5K231047UniSyn Molecular Imaging (6-3-1)Convergent Imaging Solutions20230—
+5K230393UniCam Evo SoftwareInter Medical Medizintechnik GmbH20230—
+5K210418HYPER FocusShanghai United Imaging Healthcare Co., Ltd.20210—
+5K203142Veuron-Brain-pAbHeuron Co., Ltd.20215—
+5K190379MIM on LinuxMim Software, Inc.201914—
+5K163622Lung VisionBodyvision Medical, Ltd.20176—
+5K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+5K161574Discovery MIGe Medical Systems, LLC201653
+5K141074Cortex ID SuiteGe Medical Systems, LLC20142—
+5K141477Discovery IQGe Medical Systems, LLC201403
+5K133654SceniumSiemens Medical Solutions USA, Inc.20143—
+5K121074Scenium 2.0Siemens Medical Solutions USA, Inc.201290—
+5K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+5K081792Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc.20080—
+5K071964Mim 4.1 (Seastar)Mimvista Corp.20072872
+5K071241LMS-LiverMedian Technologies20079—
+5K062163MimviewerMimvista Corp.2006166—
+5K051170Gemini GXLPhilips Medical Systems (Cleveland), Inc.20051312
+6K241266Imaging system of positron emission and X-ray computed tomography (DigitMI 930)Raysolution Healthcare Co., Ltd.20250—
+6K231576cNeuro cPETCombinostics OY20231—
+6K223800MIM – Additional TracersMim Software, Inc.20231—
+6K220256MIM-AblationMim Software, Inc.20224—
+6K221405Neurophet SCALE PETNeurophet., Inc.20222—
+6K213801Veuron-Brain-pAb2Heuron Co., Ltd.20221—
+6K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+6K211846Discovery MI Gen2Ge Medical Systems, LLC20213—
+6K202700ART-PlanTherapanacea20215—
+6K193252Contour ProtegeAIMim Software, Inc.20206—
+6K182855ProKnow DSProknow, LLC20192—
+6K172418OpenSightNovarad Corporation20185—
+6K150192SceniumSiemens Medical Solutions USA, Inc.20152—
+6K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+6K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+6K120851Communify Pacs ViewerCommunify Health, LLC20130—
+6K123528SceniumSiemens Medical Solutions USA, Inc.201279—
+6K121213VitreaadvancedVital Images, Inc.201281
+6K111332Clarity Obp SystemElekta, Ltd.20122—
+6K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+6K103576Mim 5.2 (Brachy)Mim Software, Inc.201179—
+6K103785Mobile MimMim Software, Inc.2011120—
+6K101707Fulaccess Model 1.0Fulcrum Medical, Inc.20103—
+6K101228Mirada XDMirada Medical, Ltd.201070—
+6K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+6K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC2008631
+6K070606Visio+CD Viewer# KPSCDVE01Keosys Sas20074—
+6K070248VelocityaisVelocity Medical Solutions, LLC200765—
+6K052640Gemini RaptorPhilips Medical Systems (Cleveland), Inc.20051236
+7K261916NeuroQuant PETCortechs Labs, Inc.20260—
+7K252563Neurophet SCALE PETNeurophet., Inc.20260—
+7K252496Neurophet AQUA AD PlusNeurophet., Inc.20261—
+7K251363ProKnow DSElekta Solutions AB20250—
+7K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+7K232514MIM – Dose AnalysisMim Software, Inc.20240—
+7K233572AutofusePymedix20240—
+7K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+7K231642Veuron-Brain-pAb3Heuron Co., Ltd.20230—
+7K221796Cyware 4H and Cysart 4HAbys Medical20221—
+7K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+7K221932Omni LegendGE Healthcare202221
+7K220813Art-PlanTherapanacea20224—
+7K220146VisARNovarad Corporation20220—
+7K220779XDMirada Medical, Ltd.20220—
+7K210632Contour ProtegeAIMim Software, Inc.20215—
+7K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+7K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+7K180522IGTFusionIgi Technologies20180—
+7K180129Imbio Segmentation Editing Tool softwareImbio, LLC20180—
+7K173636VelocityVarian Medical Systems, Inc.20188—