SMT-50X/H MAGNETIC RESONANCE IMAGING SYSTEM

SMT-50X/H MAGNETIC RESONANCE IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K923984) 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 March 15, 1993. Regulation: 8.