SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM

SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K932244) 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 February 17, 1994. Regulation: 8.