MRT-35A UPGRADE 8.0CD

MRT-35A UPGRADE 8.0CD is an FDA 510(k)-cleared medical device (K945798) 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 April 5, 1995. Regulation: 8.