510(k) Report

Devices descending from K020483

872 later devices reach Advantage Workstation 4.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K190379MIM on LinuxMim Software, Inc.201914—
+4K182855ProKnow DSProknow, LLC20192—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+4K170130Dynamic Coronary RoadmapPhilips Medical Systems Nederland B.V.20171—
+4K170195QuantXQuantitative Insights, Inc.20174—
+4K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V.20177—
+4K161959ClearView cCADClearview Diagnostics, Inc.2016131
+4K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+4K161419Multi Modality ViewerVital Images, Inc.20162—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K160150Vitrea CT Colon AnalysisVital Images, Inc.20160—
+4K151598VesselNavigator Rel. 1.0Philips Medical Systems Nederland B.V.20158—
+4K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+4K142647mint LesionMint Medical GmbH201523
+4K142273EmboGuidePhilips Medical Systems Nederland B.V.20151—
+4K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+4K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+4K133508Resolutionmd MobileCalgary Scientific, Inc.20145—
+4K133993Caas WorkstationPie Medical Imaging201410—
+4K133135Impax Volume Viewing 3.0Agfa Healthcare N.V.20143—
+4K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+4K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+4K132342XVWEBApteryx, Inc.20133—
+4K132742M-VU Breast DensityVucomp, Inc.201311—
+4K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC201369—
+4K120851Communify Pacs ViewerCommunify Health, LLC20130—
+4K123530Mammography Prior Enhancement (Mpe)Hologic, Inc.20120—
+4K120282CardnavPaieon, Inc.20120—
+4K120472QuantraHologic, Inc.20123—
+4K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+4K113594C-THV SystemPaieon, Inc.20120—
+4K111332Clarity Obp SystemElekta, Ltd.20122—
+4K113076Caas a-ValvePie Medical Imaging BV20121—
+4K112008Touchpacs SuiteTouch Medical Solutions, Inc.20120—
+4K112974Picture Archiving and Communications SystemCurve Dental, Inc.20117—
+4K111945Impax Next GenerationAgfa Healthcare N.V.201122
+4K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+4K111804Intellispace Pacs 4.XPhilips Healthcare Informatics, Inc.201152
+4K110139Curve ImageCurve Dental, Inc.20110—
+4K103576Mim 5.2 (Brachy)Mim Software, Inc.201179—
+4K101842ACIESKonica Minolta Medical & Graphic, Inc.20113—
+4K103385Securview DX Diagnostic WorkstationHologic, Inc.201191
+4K101707Fulaccess Model 1.0Fulcrum Medical, Inc.20103—
+4K102556Volpara, Version 1.3Matakina Technology Limited201024—
+4K101228Mirada XDMirada Medical, Ltd.201070—
+4K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+4K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+4K092954Cadstream Version 5Confirma, Inc.200983
+4K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+4K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC2008631
+4K072258BI-Rads CompanionAlmen Laboratories, Inc.20080—
+4K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions200733—
+4K071086Resolutionmd Cardiac Product Family, Model: Release 1.0Calgary Scientific, Inc.20070—
+4K071362Vital Connect 4.1Vital Images, Inc.2007113
+4K061624Vitrea, Version 3.9Vital Images, Inc.20061111
+5K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.20260—
+5K251880Archy Dental ImagingArchy Dental, Inc.20250—
+5K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+5K251363ProKnow DSElekta Solutions AB20250—
+5K243666uOmniscanShanghai United Imaging Healthcare Co., Ltd.20250—
+5K243703TechLiveDeepHealth, Inc.20250—
+5K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+5K243333rTOPRoclub GmbH20250—
+5K242329CT Collaboration LivePhilips Healthcare (Suzhou) Co., Ltd.20240—
+5K242512ROCC ConsolePhilips Medical Systems Nederland B.V.20240—
+5K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+5K240740qCT LN QuantQure.Ai Technologies20240—
+5K233572AutofusePymedix20240—
+5K231130TumorSight VizSimBioSys, Inc.20232—
+5K223800MIM – Additional TracersMim Software, Inc.20231—
+5K221612ClearRead CTRiverain Technologies, Inc.20220—
+5K220929ExcelsiorMerit Cro, Inc.20220—
+5K220256MIM-AblationMim Software, Inc.20224—
+5K220813Art-PlanTherapanacea20224—
+5K220684Oryx Cloud ImagingOryx Dental Software, Inc.20220—
+5K220779XDMirada Medical, Ltd.20220—
+5K210670BU-CADTaihao Medical, Inc.20213—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K210682SOTA Cloud ImagingSota Precision Optics, Inc. Dba Sota Imaging20211—
+5K202990NinesMeasureNines, Inc.20211—
+5K202229AI MetricsAi Metrics, LLC20200—
+5K201665Collaboration LivePhilips Ultrasound, Inc.20202—
+5K193252Contour ProtegeAIMim Software, Inc.20206—
+5K193220Aview LCSCoreline Soft Co., Ltd.20201—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+5K190442Koios DS for BreastKoios Medical, Inc.201912—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K182926IntelliSpace RadiologyPhilips Healthcare Informatics, Inc.20180—
+5K182815XVWeb 3DApteryx, Inc.20180—
+5K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation20183—
+5K180522IGTFusionIgi Technologies20180—
+5K180125PowerLook Density Assessment SoftwareIcad, Inc.20182—
+5K180129Imbio Segmentation Editing Tool softwareImbio, LLC20180—
+5K170540DM-DensityDensitas, Inc.20187—
+5K173636VelocityVarian Medical Systems, Inc.20188—
+5K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+5K173420Radiomics App v1.0Microsoft Corp.20174—
+5K172218MIM – Y90 DosimetryMim Software, Inc.201767—