AVIVA MAMMOGRAPHIC X-RAY SYSTEM

AVIVA MAMMOGRAPHIC X-RAY SYSTEM is an FDA 510(k)-cleared medical device (K915748) 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 February 3, 1992. Regulation: 8.