WINSTATION RETINAL IMAGER

WINSTATION RETINAL IMAGER is an FDA 510(k)-cleared medical device (K982689) manufactured by Ophthalmic Imaging Systems. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 22, 1998. Regulation: 8.