510(k) Report

Devices descending from K911752

849 later devices reach Icon Teleradiology System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K051127Kika Imaging Lab Viewer, Model 2.0.1.0Kika Medical, Inc.20050—
+5K042755Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation200515—
+5K043350Mistar, Model V3.2Apollo Medical Imaging Technology Pty., Ltd.200412—
+5K042700Image Medical Acquisition Station (Imas)Erad Imagemedical Corp.20040—
+5K041162Ortho-CMSMedis Medical Imaging Systems BV20042—
+5K0417375M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)Totoku Electric Co., Ltd.200414—
+5K032401OrthoviewOmsbar, Ltd.2003133—
+6K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+6K232514MIM – Dose AnalysisMim Software, Inc.20240—
+6K231225EConsole1DRTECH Corporation20233—
+6K221405Neurophet SCALE PETNeurophet., Inc.20222—
+6K213801Veuron-Brain-pAb2Heuron Co., Ltd.20221—
+6K210632Contour ProtegeAIMim Software, Inc.20215—
+6K202700ART-PlanTherapanacea20215—
+6K200275OVision Imaging SystemOphthalmic Labs, Inc.20200—
+6K182855ProKnow DSProknow, LLC20192—
+6K171098AXIS Image Management SystemSonomed, Inc.20171—
+6K161829Huvitz Imaging SystemHuvitz Co., Ltd.20171—
+6K161937CuattroDRCuattro, LLC201601
+6K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa.20161413
+6K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+6K160579Xmaru View V1 and Xmaru PACS, Medical Image Processing SoftwareRayence Co., Ltd.20165—
+6K151780CAAS WorkstationPie Medical Imaging BV20169—
+6K152172Econsole1DRTECH Corporation20156—
+6K151850McKesson CardiologyMckesson Israel, Ltd.20152—
+6K142930Exam Vue DRJpi Healthcare Co, Ltd.20151—
+6K150738VitreaViewVital Images, Inc.20158—
+6K150192SceniumSiemens Medical Solutions USA, Inc.20152—
+6K143044CAAS A-ValvePie Medical Imaging BV20150—
+6K141885CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc.201413—
+6K133022ZedviewLexi Co., Ltd.201410—
+6K133476Slit Lamps with SL Cam 5.0 Digital Imaging SolutionCarl Zeiss Meditec, AG20144—
+6K131390Jusha-M52C Medical DisplayNanjing Jusha Display Technology Co., Ltd.20131—
+6K132188Mammography Viewer SMV658Fujifilm Medical System U.S.A., Inc.20130—
+6K132667Synergy OdmTopcon Medical Systems, Inc.20139—
+6K131314Ddrcruze (Digital Mobile Diagnostic X-Ray System)Swissray Medical AG20130—
+6K130377Krystalrad New Seriesdigital Radiographic Portable Retrofit SystemMedicatech USA20131—
+6K130624CONIGlobalmed20137—
+6K130883Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa.201311—
+6K130453ExcelsiorEyekor, LLC20131—
+6K123650Arix Rad Acquisition ConsoleCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.20132—
+6K120851Communify Pacs ViewerCommunify Health, LLC20130—
+6K123575MammoworkstationImage Diagnost International GmbH20132—
+6K122938Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG2012251
+6K113696Optos AdvanceOptos Plc.20124—
+6K111332Clarity Obp SystemElekta, Ltd.20122—
+6K110869CARADiagnos, Inc.201101
+6K103576Mim 5.2 (Brachy)Mim Software, Inc.201179—
+6K103785Mobile MimMim Software, Inc.2011120—
+6K101861Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated201013—
+6K101707Fulaccess Model 1.0Fulcrum Medical, Inc.20103—
+6K102150Syngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc.201077
+6K092328Med-Seg, Model BTMS 1000Bartron Medical Imaging, Inc.20100—
+6K101228Mirada XDMirada Medical, Ltd.201070—
+6K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+6K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+6K083491NeuroscapeOlea Medical20090—
+6K082441Nordicice SoftwareNordicimaginglab AS2008732
+6K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC2008631
+6K063066Axis-V Monochrome 5 MP DisplayNational Display Systems20070—
+6K0632695MP Medical Monochrome Reference Display, Model MDM2010-5NCChi Lin Technology Co., Ltd.20071—
+6K070606Visio+CD Viewer# KPSCDVE01Keosys Sas20074—
+6K070248VelocityaisVelocity Medical Solutions, LLC200765—
+6K063327OrthoviewMerdian Technique, Ltd.200613—
+6K0620545 Megapixel Monochrome LCD Monitor, Radiforce GS510Eizo Nanao Corporation20066—
+6K0614475M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2)Totoku Electric Co., Ltd.200613—
+6K052120Lumimed Monochrome LCD Monitor, Models MM 20, MM 30 and MM50Heeyoung Co., Ltd.20052—
+6K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+6K042816Traumacad 1.2Orthocrat, Ltd.2004129—
+6K042383Rsa-CMSMedis Medical Imaging Systems BV20041—
+7K252563Neurophet SCALE PETNeurophet., Inc.20260—
+7K252496Neurophet AQUA AD PlusNeurophet., Inc.20261—
+7K251410VXvueVieworks Co., Ltd.20250—
+7K251363ProKnow DSElekta Solutions AB20250—
+7K251038Digital Radiographic Imaging Acquisition Software - DR (RiasDR)Shen Zhen Cambridge-Hit Co., Ltd.20250—
+7K241425AspenViewAspen Imaging Healthcare, Inc.20250—
+7K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+7K240243EConsole2DRTECH Corporation20240—
+7K233572AutofusePymedix20240—
+7K231642Veuron-Brain-pAb3Heuron Co., Ltd.20230—
+7K230918MasterX 800 SeriesMedicatech USA20230—
+7K220929ExcelsiorMerit Cro, Inc.20220—
+7K213527FORUMCarl Zeiss Meditec, AG20221—
+7K220813Art-PlanTherapanacea20224—
+7K220779XDMirada Medical, Ltd.20220—
+7K213057ExamVue DuoJpi Healthcare Co, Ltd.20220—
+7K213976Contour ProtégéAIMim Software, Inc.20224—
+7K211876Intellijoint VIEWIntellijoint Surgical, Inc.20210—
+7K211429NAVIPLAN - CT Planning Software for Total Hip ReplacementNaviswiss AG20210—
+7K211655aPROMISEExini Diagnostics AB20211—
+7K211542Primo SA.T.S. Applicazione Tecnologie Speciali S.R.L.20210—
+7K200704ZedViewLexi Co., Ltd.20210—
+7K201340Aquila 320 D / Aquila 320 SVmi Tecnologias Ltda20201—
+7K200385Continuum PacsIntegrated Ophthalmic Systems, Inc.20200—
+7K200132AshvinsMedicalcommunications GmbH202001
+7K193644E-Com DR-2000 DRLivermoretech, Inc.20201—
+7K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+7K192011PhoeniXSedecal., Sa.20198—
+7K191615Huvitz Imaging SystemHuvitz Co., Ltd.20190—
+7K191188ASHK100GLg Electronics20192—