Optima XR200amx, Optima XR220amx

Optima XR200amx, Optima XR220amx is an FDA 510(k)-cleared medical device (K142383) 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 September 24, 2014. Regulation: 8.