ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM

ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K023130) manufactured by Mri Devices Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 10, 2002. Regulation: 8.