ORIMS DIGITAL ANGIOGRAPHY SYSTEM

ORIMS DIGITAL ANGIOGRAPHY SYSTEM is an FDA 510(k)-cleared medical device (K952480) manufactured by Midwest Ophthalmic Instruments, 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 August 24, 1995. Regulation: 8.