510(k) Report

Devices descending from K063388

41 later devices reach Topcon 3D Oct-1000 Optical Coherence Tomography System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K0833163D Oct-1000 Mark II Optical Coherence Tomography SystemTopcon Medical Systems, Inc.200915—
+1K072971Topcon 3D Oct-1000 Optical Coherence Tomography System for Measurement of Retinal…Topcon Medical Systems, Inc.200939—
+2K093313SynergyTopcon Medical Systems, Inc.200929—
+2K092470Optical Coherence Tomography 3D Oct-2000Topcon Corp.200914—
+3K132667Synergy OdmTopcon Medical Systems, Inc.20139—
+3K130453ExcelsiorEyekor, LLC20131—
+3K122938Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG2012251
+3K112184Cirrus PhotoCarl Zeiss Meditec, Inc.201213—
+3K110006Ois Symphony Image Managment SystemOphthalmic Imaging Systems201104
+4K220929ExcelsiorMerit Cro, Inc.20220—
+4K213527FORUMCarl Zeiss Meditec, AG20221—
+4K200132AshvinsMedicalcommunications GmbH202001
+4K180229RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG20191—
+4K182318Retina WorkplaceCarl Zeiss Meditec, Inc.20180—
+4K181345Image Filing Software NAVIS-EXNidek Co., Ltd.20181—
+4K181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image SystemWelch Allyn, Inc.20181—
+4K170638Retina WorkplaceCarl Zeiss Meditec, AG20172—
+4K151952Synergy ODMTopcon Medical Systems, Inc.20158—
+4K150467Retina WorkplaceCarl Zeiss Meditec, AG20153—
+4K141922Iris Intelligent Retinal Imaging SystemIntelligent Retinal Imaging Systems, LLC20150—
+4K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG20145—
+4K141297Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20141—
+4K133217Cirrus PhotoCarl Zeiss Meditec, AG20143—
+4K130648Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20132—
+5K234076iCare ALTIUS CWCentervue S.P.A.20240—
+5K233421Rescan 700Carl Zeiss Meditec, AG20240—
+5K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…Nidek Co., Ltd.20230—
+5K200422Image Quality Analyzer (IQA)Visionquest Biomedical, Inc.20200—
+5K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc.20200—
+5K181501AfinaNeurovision Imaging, LLC20180—
+5K182376HarmonyTopcon Medical Systems, Inc.20184—
+5K180858CALLISTO eyeCarl Zeiss Meditec, AG20182—
+5K162039OptosAdvance 4.0 SoftwareOptos Plc.20172—
+6K232555HarmonyTopcon Healthcare Solutions20231—
+6K231676CALLISTO eyeCarl Zeiss Meditec, AG20231—
+6K211715RetinAI DiscoveryRetinai Medical AG20221—
+6K210396Harmony Referral SystemTopcon Healthcare Solutions EMEA Oy20211—
+7K260694Zeiss Clinic 360Carl Zeiss Meditec, AG20260—
+7K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—
+7K232944CALLISTO eyeCarl Zeiss Meditec, AG20230—
+7K232088Altris IMSAltris, Inc.20230—