510(k) Report

Devices descending from K043213

31 later devices reach Kowa VX-10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100207Non-Mydriatic Retinal Camera, Model TRC-NW8FTopcon Corp.201028—
+1K090115Retina Camera TRC-NW7SF Mark IITopcon Corp.200930—
+2K141325TRC-NW8F Plus Non-Mydriatic Retinal CameraTopcon Corp.20140—
+2K123101TRC-50DX Retinal CameraTopcon Medical Systems, Inc.20132—
+2K130289TRC-NW8 Non-Mydriatic Retinal CameraTopcon Corp.20130—
+2K123460TRC-NW300 Non-Mydriatic Retinal CameraTopcon Medical Systems, Inc.201311—
+2K112184Cirrus PhotoCarl Zeiss Meditec, Inc.201213—
+3K180229RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG20191—
+3K173119DRI OCT TritonTopcon Corporation20180—
+3K1615093D OCT-1 MaestroTopcon Corporation20168—
+3K150467Retina WorkplaceCarl Zeiss Meditec, AG20153—
+3K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG20145—
+3K141297Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20141—
+3K141481TRC-NW400 Non-Mydriatic Retinal CameraTopcon Corporation20141—
+3K133217Cirrus PhotoCarl Zeiss Meditec, AG20143—
+4K233421Rescan 700Carl Zeiss Meditec, AG20240—
+4K221111Non-Mydriatic Retinal Camera NW500Topcon Corporation20220—
+4K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc.20200—
+4K182318Retina WorkplaceCarl Zeiss Meditec, Inc.20180—
+4K180858CALLISTO eyeCarl Zeiss Meditec, AG20182—
+4K171370IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation201731
+4K170638Retina WorkplaceCarl Zeiss Meditec, AG20172—
+4K1701643D OCT-1 MaestroTopcon Corporation20175—
+5K232828IMAGEnet6 Ophthalmic Data SystemTopcon Corporation202421
+5K2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation20233—
+5K231676CALLISTO eyeCarl Zeiss Meditec, AG20231—
+5K181501AfinaNeurovision Imaging, LLC20180—
+6K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation20241—
+6K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation20242—
+6K232944CALLISTO eyeCarl Zeiss Meditec, AG20230—
+7K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—