510(k) Report

Devices descending from K960613

914 later devices reach GE Advantage Windows Review Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K052120Lumimed Monochrome LCD Monitor, Models MM 20, MM 30 and MM50Heeyoung Co., Ltd.20052—
+4K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc.20051172
+4K052023Cadimas Version 1.0Alan Penn & Associates., Inc.20050—
+4K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+4K052460Powerserver, Powerreader, Gateway and PowercacheRamsoft, Inc.20050—
+4K052305Mri Soft Tissue Motion Correction Software VA10ASiemens Medical Solutions USA, Inc.200534—
+4K050846B-Cad System, Version 1.0The Medipattern Corporation2005123—
+4K042408Iqqa-Chest Software PackageEdda Technology, Inc.20040—
+5K241038Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging20241—
+5K232976VUZE SystemVuze Medical, Ltd.20240—
+5K233660nCommand Lite SystemIonic Health20240—
+5K232744syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH20234—
+5K232346Digital Expert Access with Remote ScanningGE Healthcare20230—
+5K222662Vitrea CT Cardiac AnalysisCanon Medical Informatics, Inc.20220—
+5K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+5K201583SmartCT R1.0Philips Medical Systems Nederland B.V.20211—
+5K202700ART-PlanTherapanacea20215—
+5K200899Quantib AI NodeQuantib B.V.20200—
+5K200179Collaboration LivePhilips Health Care20204—
+5K190379MIM on LinuxMim Software, Inc.201914—
+5K182855ProKnow DSProknow, LLC20192—
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+5K170130Dynamic Coronary RoadmapPhilips Medical Systems Nederland B.V.20171—
+5K170195QuantXQuantitative Insights, Inc.20174—
+5K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V.20177—
+5K161959ClearView cCADClearview Diagnostics, Inc.2016131
+5K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+5K161419Multi Modality ViewerVital Images, Inc.20162—
+5K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+5K160150Vitrea CT Colon AnalysisVital Images, Inc.20160—
+5K151598VesselNavigator Rel. 1.0Philips Medical Systems Nederland B.V.20158—
+5K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+5K150746JUSHA-M52C Medical DisplayNanjing Jusha Display Technology Co., Ltd.20150—
+5K142647mint LesionMint Medical GmbH201523
+5K142273EmboGuidePhilips Medical Systems Nederland B.V.20151—
+5K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+5K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+5K133508Resolutionmd MobileCalgary Scientific, Inc.20145—
+5K133993Caas WorkstationPie Medical Imaging201410—
+5K133135Impax Volume Viewing 3.0Agfa Healthcare N.V.20143—
+5K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+5K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+5K132342XVWEBApteryx, Inc.20133—
+5K132742M-VU Breast DensityVucomp, Inc.201311—
+5K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC201369—
+5K123944Kostec Medical Grade LDC MonitorsKostec Co., Ltd.20130—
+5K120851Communify Pacs ViewerCommunify Health, LLC20130—
+5K123530Mammography Prior Enhancement (Mpe)Hologic, Inc.20120—
+5K120282CardnavPaieon, Inc.20120—
+5K120472QuantraHologic, Inc.20123—
+5K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+5K113594C-THV SystemPaieon, Inc.20120—
+5K111332Clarity Obp SystemElekta, Ltd.20122—
+5K113076Caas a-ValvePie Medical Imaging BV20121—
+5K112008Touchpacs SuiteTouch Medical Solutions, Inc.20120—
+5K1123545MP Monochrome LCD Monitor, Radiforce GX530Eizo Nanao Corporation20113—
+5K112974Picture Archiving and Communications SystemCurve Dental, Inc.20117—
+5K11149621.3 Inch (54CM) Monochrome Digital Mammography LCD MonitorTotoku Electric Co., Ltd.20112—
+5K111945Impax Next GenerationAgfa Healthcare N.V.201122
+5K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+5K111804Intellispace Pacs 4.XPhilips Healthcare Informatics, Inc.201152
+5K110139Curve ImageCurve Dental, Inc.20110—
+5K103576Mim 5.2 (Brachy)Mim Software, Inc.201179—
+5K101842ACIESKonica Minolta Medical & Graphic, Inc.20113—
+5K103385Securview DX Diagnostic WorkstationHologic, Inc.201191
+5K101707Fulaccess Model 1.0Fulcrum Medical, Inc.20103—
+5K102556Volpara, Version 1.3Matakina Technology Limited201024—
+5K09094721.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model MS3112 (MDL2128A)Totoku Electric Co., Ltd.20103—
+5K101228Mirada XDMirada Medical, Ltd.201070—
+5K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+5K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+5K092954Cadstream Version 5Confirma, Inc.200983
+5K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+5K082493Medical Display, MD205MG-1Nec Display Solutions, Ltd.20080—
+5K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC2008631
+5K08124221.3 Inch (53CM) Monochrome Digital Mammography LCD Monitor MS51I2, (MDL2123A)Tokotu Electric Co., Ltd.20084—
+5K072258BI-Rads CompanionAlmen Laboratories, Inc.20080—
+5K0804225 Megapixel Monochrome LCD Monitor, Model Radiforce GS520Eizo Nanao Corporation20081—
+5K07179415M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2)Totoku Electric Co., Ltd.20084—
+5K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions200733—
+5K072532Truepix LCD Medical Display Monitor, Models TX-5M, TX-3M, TX-2MDooyang Systems, Inc.20070—
+5K071086Resolutionmd Cardiac Product Family, Model: Release 1.0Calgary Scientific, Inc.20070—
+5K071362Vital Connect 4.1Vital Images, Inc.2007113
+5K061624Vitrea, Version 3.9Vital Images, Inc.20061111
+6K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.20260—
+6K251880Archy Dental ImagingArchy Dental, Inc.20250—
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K251363ProKnow DSElekta Solutions AB20250—
+6K243666uOmniscanShanghai United Imaging Healthcare Co., Ltd.20250—
+6K243703TechLiveDeepHealth, Inc.20250—
+6K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+6K243333rTOPRoclub GmbH20250—
+6K242329CT Collaboration LivePhilips Healthcare (Suzhou) Co., Ltd.20240—
+6K242512ROCC ConsolePhilips Medical Systems Nederland B.V.20240—
+6K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+6K240740qCT LN QuantQure.Ai Technologies20240—
+6K233572AutofusePymedix20240—
+6K231130TumorSight VizSimBioSys, Inc.20232—
+6K223800MIM – Additional TracersMim Software, Inc.20231—