510(k) Report

Devices descending from K010641

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+7K173420Radiomics App v1.0Microsoft Corp.20174—
+7K172218MIM – Y90 DosimetryMim Software, Inc.201767—
+7K172406Ingenuity TFPhilips Medical Systems (Cleveland), Inc.201703
+7K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+7K160371NovaPACSNovarad Corporation20165—
+7K162339SceniumSiemens Medical Solutions USA, Inc.20161—
+7K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+7K153014Mobius3DMobius Medical Systems, LP201613—
+7K151913MIM-Thin Client (mobile)Mim Software, Inc.201668—
+7K153289HealthmyneHealthmyne, Inc.20160—
+7K143514Panther StereoSeedProwess, Inc.20150—
+7K143397ICIS ViewAgfa Healthcare N.V.20156—
+7K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+7K132853NovapacsNovarad Corp.201462
+7K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+7K140651Celesteion, Pca-9000A/2Toshibamedical Systems Corporation201422
+7K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+7K140269Hermes Medical Imaging Suite V5.4Hermes Medical Solutions AB201415—
+7K123599Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland)201345
+7K130451Neuroq 3.6Syntermed, Inc.20131—
+7K123082Mobilect ViewerNephosity, Inc.20130—
+7K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa201377—
+7K130393Mirada RTXMirada Medical, Ltd.201336—
+7K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+7K123357Onq RTSOncology Systems, Inc.20120—
+7K121663ClarityElekta, Ltd.20121—
+7K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+7K122260Aycan MobileAycan Digitalsysteme GmbH20120—
+7K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+7K112930Mobile MimMim Software, Inc.201199—
+7K103483Ingenuity TF Pet/MRPhilips Healthcare (Cleveland)201104
+7K111694ASTRACandelis, Inc.20115—
+7K102000ImagysKeosys Sas20103—
+7K102687Mirada RTMirada Medical, Ltd.201037—
+7K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+7K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+7K081426Nexstar Liftoff Pet Application Software SuitePhilips Medical Systems (Cleveland), Inc.20080—
+7K081135Gemini CondorPhilips Medical Systems (Cleveland), Inc.2008013
+7K080325IGROKIgrok, LLC20080—
+8K251401PennPET Explorer Positron Emission TomographTrustees of the University of Pennsylvania20250—
+8K243884TavipilotCaranx Medical20250—
+8K243069Lumys (V1)Intradys20250—
+8K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+8K241665Omni LegendGe Medical Systems Israel, Functional Imaging202401
+8K231662Aid-UIaid20241—
+8K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+8K232189OrionXRHoth Intelligence, Inc.20230—
+8K223212Precision DLGE Healthcare20230—
+8K230023ART-PlanTherapanacea Sas20233—
+8K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+8K213976Contour ProtégéAIMim Software, Inc.20224—
+8K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+8K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+8K211655aPROMISEExini Diagnostics AB20211—
+8K210880Vereos PET/CTPhilips Medical Systems Nederland B.V.20212—
+8K200323AutoContourRadformation, Inc.20207—
+8K201232Limbus ContourLimbus Ai, Inc.20202—
+8K201798myQA iONIba Dosimetry GmbH202011
+8K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+8K191610RTappSegana, LLC20191—
+8K191761Mobius3DVarian Medical Systems, Inc.20195—
+8K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+8K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+8K182966PLANET Onco DoseDosisoft20191—
+8K182624MIM - MRT DosimetryMim Software, Inc.201853—
+8K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+8K182016Simplicit90YMirada Medical, Ltd.20183—
+8K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+8K180077NeuroQ 3.8Syntermed20180—
+8K181572Workflow BoxMirada Medical, Ltd.201825—
+8K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+8K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+8K173597Scenium VE20 SoftwareSiemens Medical Solutions USA, Inc.20180—
+8K173542Arterys Oncology DLArterys, Inc.20185—
+8K171350Collision CheckRadformation, Inc.20174—
+8K171681Hermes Medical Imaging Suite v5.7Hermes Medical Solutions AB201721
+8K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+8K171754NovaPACSNovarad Corporation201741
+8K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.201732
+8K170490Celesteion, PCA-9000A/3Toshibamedical Systems Corporation20171—
+8K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+8K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+8K161201ClearRead CTRiverain Technologies, LLC20165—
+8K153056Hermes Medical Imaging Suite v5.6Hermes Medical Solutions AB201610—
+8K153355Xeleris 4.0 Processing and Review WorkstationGE Healthcare201660—
+8K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+8K152822VidiStar HeartViewVidistar, LLC20150—
+8K151988Visible Patient SuiteVisible Patient, Sas20154—
+8K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+8K143176UltraLinqUltralinq Healthcare Solutions, Inc.20150—
+8K142196Visage Ease ProVisage Imaging GmbH20150—
+8K141536Viewing Client MobileAxon Medical Technologies Corp.20150—
+8K142631Hermes Medical Imaging Suite v5.5Hermes Medical Solutions AB201411—
+8K141855ClarityElekta, Ltd.20140—
+8K140960Picture Archiving and Communications SystemHologic, Inc.20143—
+8K133521Aze Phoenix SoftwareAze, Ltd.20140—
+8K133508Resolutionmd MobileCalgary Scientific, Inc.20145—
+8K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+8K123920Syngo.ViaSiemens AG Medical Solutions201363—