510(k) Report

Devices descending from K092565

14 later devices reach Digital Retinal Camera CX-1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123101TRC-50DX Retinal CameraTopcon Medical Systems, Inc.20132—
+1K112330Kowa VX-20Kowa Co., Ltd.20126—
+1K111612Digital Retinal CameraCanon, Inc.20113—
+2K200254Mydriatic Hyperspectral Retinal Camera (MHRC-C1)Optina Diagnostics20202—
+2K180526Eidon FACentervue S.P.A.20182—
+2K173119DRI OCT TritonTopcon Corporation20180—
+2K141325TRC-NW8F Plus Non-Mydriatic Retinal CameraTopcon Corp.20140—
+2K123208Digital Retinal CameraCanon Inc. -Medical Equipment Group20132—
+3K231230Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.20231—
+3K211328Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A.20211—
+3K201273ImageSPECTRUMCanon, Inc.20200—
+3K201122Canon non-mydriatic retinal camera CR seriesCanon, Inc.20200—
+4K250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.20250—
+4K241931OcuMet Beacon (OCUB100)Ocusciences, Inc.20250—