510(k) Report

Devices descending from K100207

28 later devices reach Non-Mydriatic Retinal Camera, Model TRC-NW8F through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141325TRC-NW8F Plus Non-Mydriatic Retinal CameraTopcon Corp.20140—
+1K130289TRC-NW8 Non-Mydriatic Retinal CameraTopcon Corp.20130—
+1K123460TRC-NW300 Non-Mydriatic Retinal CameraTopcon Medical Systems, Inc.201311—
+1K112184Cirrus PhotoCarl Zeiss Meditec, Inc.201213—
+2K180229RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG20191—
+2K1615093D OCT-1 MaestroTopcon Corporation20168—
+2K150467Retina WorkplaceCarl Zeiss Meditec, AG20153—
+2K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG20145—
+2K141297Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20141—
+2K141481TRC-NW400 Non-Mydriatic Retinal CameraTopcon Corporation20141—
+2K133217Cirrus PhotoCarl Zeiss Meditec, AG20143—
+3K233421Rescan 700Carl Zeiss Meditec, AG20240—
+3K221111Non-Mydriatic Retinal Camera NW500Topcon Corporation20220—
+3K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc.20200—
+3K182318Retina WorkplaceCarl Zeiss Meditec, Inc.20180—
+3K180858CALLISTO eyeCarl Zeiss Meditec, AG20182—
+3K173119DRI OCT TritonTopcon Corporation20180—
+3K171370IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation201731
+3K170638Retina WorkplaceCarl Zeiss Meditec, AG20172—
+3K1701643D OCT-1 MaestroTopcon Corporation20175—
+4K232828IMAGEnet6 Ophthalmic Data SystemTopcon Corporation202421
+4K2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation20233—
+4K231676CALLISTO eyeCarl Zeiss Meditec, AG20231—
+4K181501AfinaNeurovision Imaging, LLC20180—
+5K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation20241—
+5K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation20242—
+5K232944CALLISTO eyeCarl Zeiss Meditec, AG20230—
+6K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—