510(k) Report

Devices descending from K020483

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K172307Dynamic Coronary Roadmap 2.0Philips Medical Systems Nederland B.V.20170—
+5K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+5K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+5K163574Multi Modality ViewerVital Images, Inc.20171—
+5K152009DENSEEMAMMO v1.0Statlife20161—
+5K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+5K161130ResolutionMDCalgary Scientific, Inc.20164—
+5K160088Cydar EVCydar, Ltd.20167—
+5K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+5K153014Mobius3DMobius Medical Systems, LP201613—
+5K151913MIM-Thin Client (mobile)Mim Software, Inc.201668—
+5K151780CAAS WorkstationPie Medical Imaging BV20169—
+5K160315I4 (Integrated Intelligent Imaging Informatics) systemPhilips Medical Systems Nederland B.V.20163—
+5K153427Volpara Imaging SoftwareMatakina Technology, Ltd.20163—
+5K143514Panther StereoSeedProwess, Inc.20150—
+5K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+5K152028Volpara Imaging SoftwareMatakina Technologies Limited20158—
+5K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+5K151438Dentrix Ascend ImagingRealcloud Imaging, Inc.20150—
+5K150738VitreaViewVital Images, Inc.20158—
+5K143044CAAS A-ValvePie Medical Imaging BV20150—
+5K142850McKesson Radiology Mammography PlusMckesson Medical Imaging Company20150—
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+5K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+5K142037QuantraHologic, Inc.20141—
+5K140960Picture Archiving and Communications SystemHologic, Inc.20143—
+5K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+5K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+5K132684Medws Software (Variants Medview, Meddiag, Medmammo)Medecom Sarl20140—
+5K133730CO Pilot/Regius UniteaKonica Minolta, Inc.20142—
+5K130704Microdose SIPhilips Digital Mammography Sweden AB20130—
+5K130393Mirada RTXMirada Medical, Ltd.201336—
+5K123575MammoworkstationImage Diagnost International GmbH20132—
+5K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+5K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+5K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+5K121663ClarityElekta, Ltd.20121—
+5K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+5K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+5K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+5K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+5K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+5K102687Mirada RTMirada Medical, Ltd.201037—
+5K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+5K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+5K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+5K092013Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions20096—
+5K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation200910—
+5K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+5K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+5K072242Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd.20075—
+5K071331Vitrea Version 4.0Vital Images, Inc.2007821
+5K063548Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd.20076—
+6K260086CadAI-B DxBeamWorks, Inc.20260—
+6K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+6K260500ResolutionMDResolutionMD, Inc.20260—
+6K253111Aeka ImagingGood Methods Global, Inc.20260—
+6K251484CT:VQ4Dmedical Limited20250—
+6K243884TavipilotCaranx Medical20250—
+6K243189TumorSight VizSimBioSys, Inc.20241—
+6K240786AutoChamberHeartLung Corporation20241—
+6K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+6K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+6K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+6K232514MIM – Dose AnalysisMim Software, Inc.20240—
+6K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+6K222998F3Acrew Imaging, Inc.20230—
+6K230023ART-PlanTherapanacea Sas20233—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+6K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+6K212616Koios DSKoios Medical, Inc.20214—
+6K212442Cydar EV (Series B) and Cydar EV MapsCydar, Ltd.20211—
+6K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+6K210632Contour ProtegeAIMim Software, Inc.20215—
+6K212777Collaboration LivePhilips Ultrasound, Inc.20211—
+6K203785ClariSIGMAMClaripi, Inc.20210—
+6K203555AmCAD-UTAmcad Biomed Corporation20212—
+6K211506PowerLook Density Assessment V4.0Icad, Inc.20210—
+6K210066ImagePilotKonica Minolta, Inc.202111
+6K201411Visage Breast DensityVisage Imaging GmbH20210—
+6K201555EchoGo ProUltromics, Ltd.20206—
+6K200323AutoContourRadformation, Inc.20207—
+6K201710A View LCSCoreline Soft Co., Ltd.20200—
+6K201232Limbus ContourLimbus Ai, Inc.20202—
+6K201798myQA iONIba Dosimetry GmbH202011
+6K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+6K192973densitas densityaiDensitas, Inc.20205—
+6K191610RTappSegana, LLC20191—
+6K191761Mobius3DVarian Medical Systems, Inc.20195—
+6K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+6K190694Unifi Workspace v1.0.0Hologic, Inc.20192—
+6K183248Synapse Enterprise Viewer Version 1.0Fujifilm Corporation20190—
+6K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+6K182966PLANET Onco DoseDosisoft20191—
+6K182624MIM - MRT DosimetryMim Software, Inc.201853—
+6K182016Simplicit90YMirada Medical, Ltd.20183—
+6K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+6K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—