DIGITAL RETINAL CAMERA CX-1

DIGITAL RETINAL CAMERA CX-1 is an FDA 510(k)-cleared medical device (K092565) manufactured by Canon Components, 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 March 17, 2010. Regulation: 8.