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
+7K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+7K161130ResolutionMDCalgary Scientific, Inc.20164—
+7K160088Cydar EVCydar, Ltd.20167—
+7K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+7K153014Mobius3DMobius Medical Systems, LP201613—
+7K151913MIM-Thin Client (mobile)Mim Software, Inc.201668—
+7K151780CAAS WorkstationPie Medical Imaging BV20169—
+7K160315I4 (Integrated Intelligent Imaging Informatics) systemPhilips Medical Systems Nederland B.V.20163—
+7K153427Volpara Imaging SoftwareMatakina Technology, Ltd.20163—
+7K143514Panther StereoSeedProwess, Inc.20150—
+7K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+7K152028Volpara Imaging SoftwareMatakina Technologies Limited20158—
+7K151371Corporate Dental Imaging (CDI) ApplicationU.S. Army Dental Command (Dencom)20150—
+7K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+7K151438Dentrix Ascend ImagingRealcloud Imaging, Inc.20150—
+7K150738VitreaViewVital Images, Inc.20158—
+7K143044CAAS A-ValvePie Medical Imaging BV20150—
+7K142850McKesson Radiology Mammography PlusMckesson Medical Imaging Company20150—
+7K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+7K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+7K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+7K141881RapidresultsRamsoft, Inc.20145—
+7K142037QuantraHologic, Inc.20141—
+7K140960Picture Archiving and Communications SystemHologic, Inc.20143—
+7K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+7K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+7K132684Medws Software (Variants Medview, Meddiag, Medmammo)Medecom Sarl20140—
+7K133730CO Pilot/Regius UniteaKonica Minolta, Inc.20142—
+7K130704Microdose SIPhilips Digital Mammography Sweden AB20130—
+7K13113721.3 Inch Monochrome Digital Mammography LCD Monitor MS55I2 (ML21055, MD211G5)Jvckenwood Corporation20131—
+7K130393Mirada RTXMirada Medical, Ltd.201336—
+7K123575MammoworkstationImage Diagnost International GmbH20132—
+7K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+7K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+7K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+7K121663ClarityElekta, Ltd.20121—
+7K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+7K1204518MP Color LCD Monitor, Rediforce RX840Eizo Nanao Corporation20122—
+7K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+7K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+7K112145Monochrome Digital Mammography LCD Monitor MS33I2Totoku Electric Co., Ltd.20112—
+7K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+7K103546Aycan Workstation Osirix ProAycan Digitalsysteme GmbH20110—
+7K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+7K102687Mirada RTMirada Medical, Ltd.201037—
+7K101342Osirix MDPixmeo Sarl201044—
+7K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+7K101796Pacsmate MMD-5201M MonitorIei Technology Corp.20100—
+7K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+7K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+7K092013Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions20096—
+7K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation200910—
+7K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+7K08194521.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A)Totoku Electric Co., Ltd.20083—
+7K082041Fiatlux VisualizeFiatlux Imaging, Inc.20081—
+7K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+7K073176Kanteron Dicom Station (KDS), Model 3.0Monica Veytia20080—
+7K072242Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd.20075—
+7K071331Vitrea Version 4.0Vital Images, Inc.2007821
+7K063548Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd.20076—
+8K260086CadAI-B DxBeamWorks, Inc.20260—
+8K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+8K260500ResolutionMDResolutionMD, Inc.20260—
+8K253111Aeka ImagingGood Methods Global, Inc.20260—
+8K251030Sirona Advanced Imaging SuiteSirona Medical20250—
+8K251484CT:VQ4Dmedical Limited20250—
+8K243884TavipilotCaranx Medical20250—
+8K242838QuickRadAikenist Technologies Pvt, Ltd.20250—
+8K243189TumorSight VizSimBioSys, Inc.20241—
+8K240786AutoChamberHeartLung Corporation20241—
+8K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+8K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+8K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+8K232514MIM – Dose AnalysisMim Software, Inc.20240—
+8K232891Carpl (Carpl)Carpl Ai, Inc.20242—
+8K232589Horos MD™Icat Solutions, Ltd.20241—
+8K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+8K222998F3Acrew Imaging, Inc.20230—
+8K230023ART-PlanTherapanacea Sas20233—
+8K222476OmegaAI Image ViewerRamsoft, Inc.20223—
+8K212565CoverScan v1Perspectum, Ltd.20221—
+8K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+8K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+8K212616Koios DSKoios Medical, Inc.20214—
+8K212442Cydar EV (Series B) and Cydar EV MapsCydar, Ltd.20211—
+8K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+8K210632Contour ProtegeAIMim Software, Inc.20215—
+8K212777Collaboration LivePhilips Ultrasound, Inc.20211—
+8K203785ClariSIGMAMClaripi, Inc.20210—
+8K203555AmCAD-UTAmcad Biomed Corporation20212—
+8K211506PowerLook Density Assessment V4.0Icad, Inc.20210—
+8K211312Universal ViewerGE Healthcare202112
+8K210066ImagePilotKonica Minolta, Inc.202111
+8K201411Visage Breast DensityVisage Imaging GmbH20210—
+8K201555EchoGo ProUltromics, Ltd.20206—
+8K200323AutoContourRadformation, Inc.20207—
+8K201092LSNImaging Biometrics, LLC20200—
+8K201710A View LCSCoreline Soft Co., Ltd.20200—
+8K201232Limbus ContourLimbus Ai, Inc.20202—
+8K201798myQA iONIba Dosimetry GmbH202011