ANGIOSCAN (AS STAND ALONE INSTRUMENT)

ANGIOSCAN (AS STAND ALONE INSTRUMENT) is an FDA 510(k)-cleared medical device (K951132) manufactured by Carl Zeiss Meditec, 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 25, 1995. Regulation: 8.