IREX PS, PORTABLE SCANNER AND 118

IREX PS, PORTABLE SCANNER AND 118 is an FDA 510(k)-cleared medical device (K844404) manufactured by Irex Corp.. 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 3, 1985. Regulation: 8.