1.5T GEM RT OPEN ARRAY

1.5T GEM RT OPEN ARRAY is an FDA 510(k)-cleared medical device (K123327) 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 January 10, 2013. Regulation: 8.