CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI

CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI is an FDA 510(k)-cleared medical device (K031629) manufactured by Canon USA, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 5, 2003. Regulation: 8.