MODEL ESP-200 MAMMOGRAPHIC SYSTEM

MODEL ESP-200 MAMMOGRAPHIC SYSTEM is an FDA 510(k)-cleared medical device (K884345) manufactured by Acoma Medical Imaging, 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 March 22, 1989. Regulation: 8.