MINXRAY 500M MAMMOGRAPHIC SYSTEM

MINXRAY 500M MAMMOGRAPHIC SYSTEM is an FDA 510(k)-cleared medical device (K854510) manufactured by Minxray, 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 December 31, 1985. Regulation: 8.