MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM

MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM is an FDA 510(k)-cleared medical device (K912974) manufactured by Elscint, 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 September 18, 1991. Regulation: 8.