DUOFLEX COIL SUITE (1.5T)

DUOFLEX COIL SUITE (1.5T) is an FDA 510(k)-cleared medical device (K130706) manufactured by Mr 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 July 24, 2013. Regulation: 8.