CAROTID COIL GE 1.5T

CAROTID COIL GE 1.5T is an FDA 510(k)-cleared medical device (K113280) manufactured by Tursiop Technologies, 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 November 22, 2011. Regulation: 8.