IMRIS iMRI 3T V

IMRIS iMRI 3T V is an FDA 510(k)-cleared medical device (K212367) manufactured by Deerfield Imaging, 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 August 22, 2021. Regulation: 8.