510(k) Report

Devices descending from K942120

1,037 later devices reach Advantage Windows Diagnostic X-Ray Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K132742M-VU Breast DensityVucomp, Inc.201311—
+6K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC201369—
+6K131977Centricity Universal Viewer Zero Footprint ClientGE Healthcare201368
+6K123944Kostec Medical Grade LDC MonitorsKostec Co., Ltd.20130—
+6K123530Mammography Prior Enhancement (Mpe)Hologic, Inc.20120—
+6K120282CardnavPaieon, Inc.20120—
+6K120472QuantraHologic, Inc.20123—
+6K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+6K113594C-THV SystemPaieon, Inc.20120—
+6K111332Clarity Obp SystemElekta, Ltd.20122—
+6K113076Caas a-ValvePie Medical Imaging BV20121—
+6K1123545MP Monochrome LCD Monitor, Radiforce GX530Eizo Nanao Corporation20113—
+6K112974Picture Archiving and Communications SystemCurve Dental, Inc.20117—
+6K11149621.3 Inch (54CM) Monochrome Digital Mammography LCD MonitorTotoku Electric Co., Ltd.20112—
+6K111660Xelis CardiacInfinitt Co., Ltd.20110—
+6K111613Xelis FusionInfinitt Co., Ltd.20110—
+6K111945Impax Next GenerationAgfa Healthcare N.V.201122
+6K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+6K111804Intellispace Pacs 4.XPhilips Healthcare Informatics, Inc.201152
+6K103130Xelis 3DInfinitt Co., Ltd.20110—
+6K110139Curve ImageCurve Dental, Inc.20110—
+6K103576Mim 5.2 (Brachy)Mim Software, Inc.201179—
+6K101842ACIESKonica Minolta Medical & Graphic, Inc.20113—
+6K103385Securview DX Diagnostic WorkstationHologic, Inc.201191
+6K100837Pacentric Connect, Traveler and WebFimreite Software AS20100—
+6K101707Fulaccess Model 1.0Fulcrum Medical, Inc.20103—
+6K102556Volpara, Version 1.3Matakina Technology Limited201024—
+6K102684Xelis DentalInfinitt Co., Ltd.20102—
+6K09094721.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model MS3112 (MDL2128A)Totoku Electric Co., Ltd.20103—
+6K092328Med-Seg, Model BTMS 1000Bartron Medical Imaging, Inc.20100—
+6K101228Mirada XDMirada Medical, Ltd.201070—
+6K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+6K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+6K092954Cadstream Version 5Confirma, Inc.200983
+6K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+6K082493Medical Display, MD205MG-1Nec Display Solutions, Ltd.20080—
+6K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC2008631
+6K08124221.3 Inch (53CM) Monochrome Digital Mammography LCD Monitor MS51I2, (MDL2123A)Tokotu Electric Co., Ltd.20084—
+6K072258BI-Rads CompanionAlmen Laboratories, Inc.20080—
+6K0804225 Megapixel Monochrome LCD Monitor, Model Radiforce GS520Eizo Nanao Corporation20081—
+6K07179415M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2)Totoku Electric Co., Ltd.20084—
+6K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions200733—
+6K072532Truepix LCD Medical Display Monitor, Models TX-5M, TX-3M, TX-2MDooyang Systems, Inc.20070—
+6K071086Resolutionmd Cardiac Product Family, Model: Release 1.0Calgary Scientific, Inc.20070—
+6K071362Vital Connect 4.1Vital Images, Inc.2007113
+6K063470Aycan Workstation OsirixAycan Digitalsysteme GmbH200749—
+6K061624Vitrea, Version 3.9Vital Images, Inc.20061111
+7K261874Syneris PACS v.1.0.1.0Syneris20260—
+7K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.20260—
+7K251880Archy Dental ImagingArchy Dental, Inc.20250—
+7K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+7K251363ProKnow DSElekta Solutions AB20250—
+7K243666uOmniscanShanghai United Imaging Healthcare Co., Ltd.20250—
+7K243703TechLiveDeepHealth, Inc.20250—
+7K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+7K243333rTOPRoclub GmbH20250—
+7K242329CT Collaboration LivePhilips Healthcare (Suzhou) Co., Ltd.20240—
+7K242512ROCC ConsolePhilips Medical Systems Nederland B.V.20240—
+7K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+7K240740qCT LN QuantQure.Ai Technologies20240—
+7K233572AutofusePymedix20240—
+7K231130TumorSight VizSimBioSys, Inc.20232—
+7K222781AugmentoDeeptek Medical Imaging Private Limited20234—
+7K223800MIM – Additional TracersMim Software, Inc.20231—
+7K221612ClearRead CTRiverain Technologies, Inc.20220—
+7K220929ExcelsiorMerit Cro, Inc.20220—
+7K220256MIM-AblationMim Software, Inc.20224—
+7K220813Art-PlanTherapanacea20224—
+7K220684Oryx Cloud ImagingOryx Dental Software, Inc.20220—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K220779XDMirada Medical, Ltd.20220—
+7K210670BU-CADTaihao Medical, Inc.20213—
+7K210682SOTA Cloud ImagingSota Precision Optics, Inc. Dba Sota Imaging20211—
+7K202990NinesMeasureNines, Inc.20211—
+7K202229AI MetricsAi Metrics, LLC20200—
+7K201665Collaboration LivePhilips Ultrasound, Inc.20202—
+7K193252Contour ProtegeAIMim Software, Inc.20206—
+7K193220Aview LCSCoreline Soft Co., Ltd.20201—
+7K200315Ziostation2Ziosoft, Inc.20200—
+7K193369Xelis Dental 2.0Infinitt Healthcare Co., Ltd.20200—
+7K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+7K190442Koios DS for BreastKoios Medical, Inc.201912—
+7K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+7K182419Centricity Universal ViewerGE Healthcare201828
+7K182926IntelliSpace RadiologyPhilips Healthcare Informatics, Inc.20180—
+7K182815XVWeb 3DApteryx, Inc.20180—
+7K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation20183—
+7K180522IGTFusionIgi Technologies20180—
+7K180125PowerLook Density Assessment SoftwareIcad, Inc.20182—
+7K180129Imbio Segmentation Editing Tool softwareImbio, LLC20180—
+7K170540DM-DensityDensitas, Inc.20187—
+7K173636VelocityVarian Medical Systems, Inc.20188—
+7K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+7K173420Radiomics App v1.0Microsoft Corp.20174—
+7K172218MIM – Y90 DosimetryMim Software, Inc.201767—
+7K172307Dynamic Coronary Roadmap 2.0Philips Medical Systems Nederland B.V.20170—
+7K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+7K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+7K163574Multi Modality ViewerVital Images, Inc.20171—
+7K152009DENSEEMAMMO v1.0Statlife20161—