510(k) Report

Devices descending from K911752

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K190866XmaruView V1 (Xmaru Chiroview, Xmaru Podview)Rayence Co., Ltd.20190—
+7K182537RADMAX Digital Imaging SoftwareDRGEM Corporation20190—
+7K183478ClearON MobileRayence Co., Ltd.20190—
+7K182318Retina WorkplaceCarl Zeiss Meditec, Inc.20180—
+7K181874MX40 Mobile Digital X-ray SystemHuestis Machine Corporation20181—
+7K180522IGTFusionIgi Technologies20180—
+7K181345Image Filing Software NAVIS-EXNidek Co., Ltd.20181—
+7K181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image SystemWelch Allyn, Inc.20181—
+7K181080McKesson CardiologyChange Healthcare Israel, Ltd.20181—
+7K180019CAAS WorkstationPie Medical Imaging BV20188—
+7K171847Corin Optimized Positioning System (OPS™) PlanCorin U.S.A. Limited20186—
+7K180129Imbio Segmentation Editing Tool softwareImbio, LLC20180—
+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—
+7K173018MDR17 Mobile Direct Radiographic SystemDel Medical, Inc.20170—
+7K171068OrthoView 7.2Meridian Technique, Ltd.20170—
+7K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+7K163232Vitrea ViewVital Images, Inc.20177—
+7K170729Examion X-AQSExamion GmbH20170—
+7K170638Retina WorkplaceCarl Zeiss Meditec, AG20172—
+7K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc.201712—
+7K162684SL 220Carl Zeiss Meditec, AG20171—
+7K163564Slit Lamp SL-2000Nidek Co., Ltd.20170—
+7K163405360KS Implant Positioning SystemKico Knee Innovation Company Pty Limited20170—
+7K162529DigiX FDXAllengers Medical Systems Limited20176—
+7K161607VisuluxCarl Zeiss Meditec, AG20170—
+7K162670RSM 1824C with RConsole1DRTECH Corporation20174—
+7K162039OptosAdvance 4.0 SoftwareOptos Plc.20172—
+7K162687Paragon 2Meridian Medical Systems, LLC20160—
+7K160371NovaPACSNovarad Corporation20165—
+7K162339SceniumSiemens Medical Solutions USA, Inc.20161—
+7K160284JointPointJointpoint, Inc.201621—
+7K153014Mobius3DMobius Medical Systems, LP201613—
+7K151913MIM-Thin Client (mobile)Mim Software, Inc.201668—
+7K153653DICOM ViewerBrainlab AG20164—
+7K143514Panther StereoSeedProwess, Inc.20150—
+7K151952Synergy ODMTopcon Medical Systems, Inc.20158—
+7K143397ICIS ViewAgfa Healthcare N.V.20156—
+7K150467Retina WorkplaceCarl Zeiss Meditec, AG20153—
+7K150746JUSHA-M52C Medical DisplayNanjing Jusha Display Technology Co., Ltd.20150—
+7K143361Mammo WorkstationGE Healthcare20151—
+7K141922Iris Intelligent Retinal Imaging SystemIntelligent Retinal Imaging Systems, LLC20150—
+7K142944ArthroPlan Digital Templating SoftwareArthromeda, Inc.20140—
+7K132853NovapacsNovarad Corp.201462
+7K141297Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20141—
+7K141068Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG20148—
+7K140825Delworks DR SystemDel Medical, Inc.20147—
+7K141329RadspaTelerad Tech Private Limited20140—
+7K133966Model-Based Rsa SoftwareHalifax Biomedical, Inc.20140—
+7K132763Advanced ViewerBrainlab AG20141—
+7K123944Kostec Medical Grade LDC MonitorsKostec Co., Ltd.20130—
+7K130648Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20132—
+7K123082Mobilect ViewerNephosity, Inc.20130—
+7K130393Mirada RTXMirada Medical, Ltd.201336—
+7K123464Callisto EyeCarl Zeiss Meditec, AG20136—
+7K123922Syngo DynamicsSiemens Medical Solutions USA, Inc.20135—
+7K123357Onq RTSOncology Systems, Inc.20120—
+7K121663ClarityElekta, Ltd.20121—
+7K122260Aycan MobileAycan Digitalsysteme GmbH20120—
+7K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+7K112930Mobile MimMim Software, Inc.201199—
+7K1123545MP Monochrome LCD Monitor, Radiforce GX530Eizo Nanao Corporation20113—
+7K11149621.3 Inch (54CM) Monochrome Digital Mammography LCD MonitorTotoku Electric Co., Ltd.20112—
+7K111694ASTRACandelis, Inc.20115—
+7K102687Mirada RTMirada Medical, Ltd.201037—
+7K09094721.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model MS3112 (MDL2128A)Totoku Electric Co., Ltd.20103—
+7K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+7K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+7K090546Modification to Nordicice SoftwareNordicimaginglab AS200972—
+7K082493Medical Display, MD205MG-1Nec Display Solutions, Ltd.20080—
+7K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+7K08124221.3 Inch (53CM) Monochrome Digital Mammography LCD Monitor MS51I2, (MDL2123A)Tokotu Electric Co., Ltd.20084—
+7K080325IGROKIgrok, LLC20080—
+7K073714Traumacad Version 2.0Orthocrat, Ltd.2008117—
+7K0804225 Megapixel Monochrome LCD Monitor, Model Radiforce GS520Eizo Nanao Corporation20081—
+7K07179415M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2)Totoku Electric Co., Ltd.20084—
+7K073271OrthogonAgfa Healthcare Corporation20070—
+7K072532Truepix LCD Medical Display Monitor, Models TX-5M, TX-3M, TX-2MDooyang Systems, Inc.20070—
+8K253834Visuref 600Carl Zeiss Vision GmbH20260—
+8K253551VELYS™ Hip NavigationDepuy Ireland UC20260—
+8K251883MIM – LesionID ProMim Software, Inc.20250—
+8K251355X1-FFRSpectrawave, Inc.20250—
+8K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited20250—
+8K234076iCare ALTIUS CWCentervue S.P.A.20240—
+8K232147CAAS WorkstationPie Medical Imaging BV20241—
+8K240284Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex…Shenzhen Browiner Tech Co., Ltd.20240—
+8K231662Aid-UIaid20241—
+8K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+8K230023ART-PlanTherapanacea Sas20233—
+8K223774Contour ProtégéAIMim Software, Inc.20233—
+8K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…Nidek Co., Ltd.20230—
+8K220590aPROMISE XExini Diagnostics AB20220—
+8K211715RetinAI DiscoveryRetinai Medical AG20221—
+8K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+8K212720nordicDSCNordicneurolab AS20222—
+8K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+8K212137X-CleverLg Electronics.Inc20211—
+8K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—