IMRI 1.5T AND IMRI 3T S

IMRI 1.5T AND IMRI 3T S is an FDA 510(k)-cleared medical device (K133692) manufactured by Imris, 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 February 9, 2014. Regulation: 8.