SMT-50XM MAGNETIC RESONANCE IMAGING SYSTEM

SMT-50XM MAGNETIC RESONANCE IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K925107) manufactured by Shimadzu Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 14, 1993. Regulation: 8.