3.0T GEM RT Open Array

3.0T GEM RT Open Array is an FDA 510(k)-cleared medical device (K143389) manufactured by Ge Healthcare Coils (Usa Instruments, Inc.). This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 5, 2015. Regulation: 8.