MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL

MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL is an FDA 510(k)-cleared medical device (K031056) manufactured by 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 May 7, 2003. Regulation: 8.