MRII Cranial Drill and Accessories

MRII Cranial Drill and Accessories is an FDA 510(k)-cleared medical device (K160129) manufactured by Mri Interventions, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 25, 2016. Regulation: 8.