IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM

IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM is an FDA 510(k)-cleared medical device (K971685) manufactured by Tomey Corporation USA. 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 23, 1997. Regulation: 8.