510(k) Report

Devices descending from K040172

463 later devices reach Modification to GE Discovery LS System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103710WBR Xpress PetUltraspect, Ltd.20110—
+1K041955Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc.2004652
+1K041543GE Discovery STGE Healthcare20043961
+1K041220GE Discovery ST SystemGE Medical Systems20040—
+2K113086ACQATexas Medical Imaging Consultants20120—
+2K062650EP Navigator SoftwarePhilips Medical Systems200649—
+2K050559GE Discovery VCT SystemGE Medical Systems2005131
+2K042863SceniumSiemens Molecular Imaging, Ltd.2004380—
+2K042935Gemini GXLPhilips Medical Systems (Cleveland), Inc.2004142
+3K163622Lung VisionBodyvision Medical, Ltd.20176—
+3K151403Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron…Neusoft Medical Systems Co., Ltd.20150—
+3K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+3K082244Pca-8000A, Mark 11, Pet / CT SystemToshiba America Medical Systems, In.C20080—
+3K081496Optima Pet/CT 560Ge Medical Systems, LLC2008107
+3K062393GE Vantage Pet Neuro SoftwareGE Healthcare20063—
+3K061545Scenium 1.1Siemens Molecular Imaging, Ltd.200691—
+3K060816Mim 4.0 (NeuroMimvista Corp.20063501
+3K051170Gemini GXLPhilips Medical Systems (Cleveland), Inc.20051312
+4K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+4K203142Veuron-Brain-pAbHeuron Co., Ltd.20215—
+4K190379MIM on LinuxMim Software, Inc.201914—
+4K172418OpenSightNovarad Corporation20185—
+4K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+4K141074Cortex ID SuiteGe Medical Systems, LLC20142—
+4K133657Discovery Pet/CT 710Ge Medical Systems, LLC201474
+4K133654SceniumSiemens Medical Solutions USA, Inc.20143—
+4K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+4K121074Scenium 2.0Siemens Medical Solutions USA, Inc.201290—
+4K113408Q. Freeze (Motion VUE2)Ge Medical Systems, LLC20121—
+4K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+4K071964Mim 4.1 (Seastar)Mimvista Corp.20072872
+4K062163MimviewerMimvista Corp.2006166—
+4K052640Gemini RaptorPhilips Medical Systems (Cleveland), Inc.20051236
+5K231576cNeuro cPETCombinostics OY20231—
+5K223800MIM – Additional TracersMim Software, Inc.20231—
+5K221796Cyware 4H and Cysart 4HAbys Medical20221—
+5K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+5K220256MIM-AblationMim Software, Inc.20224—
+5K221405Neurophet SCALE PETNeurophet., Inc.20222—
+5K220146VisARNovarad Corporation20220—
+5K213801Veuron-Brain-pAb2Heuron Co., Ltd.20221—
+5K210418HYPER FocusShanghai United Imaging Healthcare Co., Ltd.20210—
+5K202700ART-PlanTherapanacea20215—
+5K193252Contour ProtegeAIMim Software, Inc.20206—
+5K182855ProKnow DSProknow, LLC20192—
+5K172406Ingenuity TFPhilips Medical Systems (Cleveland), Inc.201703
+5K161574Discovery MIGe Medical Systems, LLC201653
+5K150192SceniumSiemens Medical Solutions USA, Inc.20152—
+5K141477Discovery IQGe Medical Systems, LLC201403
+5K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+5K140651Celesteion, Pca-9000A/2Toshibamedical Systems Corporation201422
+5K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+5K123599Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland)201345
+5K120851Communify Pacs ViewerCommunify Health, LLC20130—
+5K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+5K123528SceniumSiemens Medical Solutions USA, Inc.201279—
+5K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+5K111332Clarity Obp SystemElekta, Ltd.20122—
+5K103483Ingenuity TF Pet/MRPhilips Healthcare (Cleveland)201104
+5K103576Mim 5.2 (Brachy)Mim Software, Inc.201179—
+5K103785Mobile MimMim Software, Inc.2011120—
+5K101707Fulaccess Model 1.0Fulcrum Medical, Inc.20103—
+5K101228Mirada XDMirada Medical, Ltd.201070—
+5K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+5K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC2008631
+5K081426Nexstar Liftoff Pet Application Software SuitePhilips Medical Systems (Cleveland), Inc.20080—
+5K081135Gemini CondorPhilips Medical Systems (Cleveland), Inc.2008013
+5K070606Visio+CD Viewer# KPSCDVE01Keosys Sas20074—
+5K070248VelocityaisVelocity Medical Solutions, LLC200765—
+6K261916NeuroQuant PETCortechs Labs, Inc.20260—
+6K252563Neurophet SCALE PETNeurophet., Inc.20260—
+6K252496Neurophet AQUA AD PlusNeurophet., Inc.20261—
+6K251401PennPET Explorer Positron Emission TomographTrustees of the University of Pennsylvania20250—
+6K251363ProKnow DSElekta Solutions AB20250—
+6K243884TavipilotCaranx Medical20250—
+6K243069Lumys (V1)Intradys20250—
+6K241266Imaging system of positron emission and X-ray computed tomography (DigitMI 930)Raysolution Healthcare Co., Ltd.20250—
+6K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+6K232514MIM – Dose AnalysisMim Software, Inc.20240—
+6K233572AutofusePymedix20240—
+6K231642Veuron-Brain-pAb3Heuron Co., Ltd.20230—
+6K232189OrionXRHoth Intelligence, Inc.20230—
+6K220813Art-PlanTherapanacea20224—
+6K220779XDMirada Medical, Ltd.20220—
+6K210632Contour ProtegeAIMim Software, Inc.20215—
+6K211846Discovery MI Gen2Ge Medical Systems, LLC20213—
+6K210880Vereos PET/CTPhilips Medical Systems Nederland B.V.20212—
+6K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+6K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+6K180522IGTFusionIgi Technologies20180—
+6K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+6K180129Imbio Segmentation Editing Tool softwareImbio, LLC20180—
+6K173636VelocityVarian Medical Systems, Inc.20188—
+6K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+6K173420Radiomics App v1.0Microsoft Corp.20174—
+6K172218MIM – Y90 DosimetryMim Software, Inc.201767—
+6K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+6K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+6K170490Celesteion, PCA-9000A/3Toshibamedical Systems Corporation20171—
+6K160371NovaPACSNovarad Corporation20165—