MRT 35-A (TM)

MRT 35-A (TM) is an FDA 510(k)-cleared medical device (K905441) manufactured by Toshiba America Mri, 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 December 13, 1990. Regulation: 8.