GYREX PRIMA 1TG 1.0T MRI SYSTEM

GYREX PRIMA 1TG 1.0T MRI SYSTEM is an FDA 510(k)-cleared medical device (K970990) manufactured by Elscint Mr, 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 August 24, 1997. Regulation: 8.