510(k) Report

Devices descending from K013694

61 later devices reach Nidek Advanced Vision Information System (Navis) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142423EyeSuite ImagingHaag-Streit AG201421
+1K110129Righton Zoom Slit Lamp Microscope with Photo OptionRightmedical Products, LLC20115—
+1K110006Ois Symphony Image Managment SystemOphthalmic Imaging Systems201104
+1K093313SynergyTopcon Medical Systems, Inc.200929—
+1K090266MatchedflickerEyeic Corporation20090—
+1K090439FORUMCarl Zeiss Meditec, Inc.200932—
+1K082364Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or…Topcon Corp.200850—
+2K200275OVision Imaging SystemOphthalmic Labs, Inc.20200—
+2K171098AXIS Image Management SystemSonomed, Inc.20171—
+2K161829Huvitz Imaging SystemHuvitz Co., Ltd.20171—
+2K133476Slit Lamps with SL Cam 5.0 Digital Imaging SolutionCarl Zeiss Meditec, AG20144—
+2K132667Synergy OdmTopcon Medical Systems, Inc.20139—
+2K130453ExcelsiorEyekor, LLC20131—
+2K122938Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG2012251
+2K113696Optos AdvanceOptos Plc.20124—
+2K110869CARADiagnos, Inc.201101
+2K101861Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated201013—
+3K220929ExcelsiorMerit Cro, Inc.20220—
+3K213527FORUMCarl Zeiss Meditec, AG20221—
+3K200385Continuum PacsIntegrated Ophthalmic Systems, Inc.20200—
+3K200132AshvinsMedicalcommunications GmbH202001
+3K191615Huvitz Imaging SystemHuvitz Co., Ltd.20190—
+3K182318Retina WorkplaceCarl Zeiss Meditec, Inc.20180—
+3K181345Image Filing Software NAVIS-EXNidek Co., Ltd.20181—
+3K181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image SystemWelch Allyn, Inc.20181—
+3K170638Retina WorkplaceCarl Zeiss Meditec, AG20172—
+3K162684SL 220Carl Zeiss Meditec, AG20171—
+3K163564Slit Lamp SL-2000Nidek Co., Ltd.20170—
+3K161607VisuluxCarl Zeiss Meditec, AG20170—
+3K162039OptosAdvance 4.0 SoftwareOptos Plc.20172—
+3K151952Synergy ODMTopcon Medical Systems, Inc.20158—
+3K150467Retina WorkplaceCarl Zeiss Meditec, AG20153—
+3K141922Iris Intelligent Retinal Imaging SystemIntelligent Retinal Imaging Systems, LLC20150—
+3K141297Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20141—
+3K141068Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG20148—
+3K130648Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20132—
+3K123464Callisto EyeCarl Zeiss Meditec, AG20136—
+4K253834Visuref 600Carl Zeiss Vision GmbH20260—
+4K234076iCare ALTIUS CWCentervue S.P.A.20240—
+4K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…Nidek Co., Ltd.20230—
+4K211715RetinAI DiscoveryRetinai Medical AG20221—
+4K200422Image Quality Analyzer (IQA)Visionquest Biomedical, Inc.20200—
+4K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc.20200—
+4K181501AfinaNeurovision Imaging, LLC20180—
+4K182376HarmonyTopcon Medical Systems, Inc.20184—
+4K180858CALLISTO eyeCarl Zeiss Meditec, AG20182—
+4K143275IOLMaster700Carl Zeiss Meditec, Inc.20154—
+4K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG20145—
+5K232555HarmonyTopcon Healthcare Solutions20231—
+5K231676CALLISTO eyeCarl Zeiss Meditec, AG20231—
+5K232088Altris IMSAltris, Inc.20230—
+5K210396Harmony Referral SystemTopcon Healthcare Solutions EMEA Oy20211—
+5K191051ARGOSSantec Corporation20190—
+5K180229RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG20191—
+5K170171IOLMaster 700Carl Zeiss Meditec, AG201731
+6K260694Zeiss Clinic 360Carl Zeiss Meditec, AG20260—
+6K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—
+6K233421Rescan 700Carl Zeiss Meditec, AG20240—
+6K232944CALLISTO eyeCarl Zeiss Meditec, AG20230—
+6K173771IOLMaster 700Carl Zeiss Meditec, AG201811
+7K252633Unity DX (Udx)Cylite Pty., Ltd.20250—