Optima XR240amx, AutoGrid

Optima XR240amx, AutoGrid is an FDA 510(k)-cleared medical device (K173602) 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 January 11, 2018. Regulation: 8.