ILUMA VISION MODEL VERSION 2.2

ILUMA VISION MODEL VERSION 2.2 is an FDA 510(k)-cleared medical device (K094064) manufactured by 3M Imtec. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 29, 2010. Regulation: 8.