Ilumien Optis, Optis Integrated, Optis Mobile

Ilumien Optis, Optis Integrated, Optis Mobile is an FDA 510(k)-cleared medical device (K183320) manufactured by St. Jude Medical (Now Abbott Medical). 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 1, 2019. Regulation: 8.