BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX

BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX is an FDA 510(k)-cleared medical device (K103476) manufactured by Ge Medical Systems, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 15, 2011. Regulation: 8.