ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM

ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM is an FDA 510(k)-cleared medical device (K900989) manufactured by Fischer Imaging 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 March 27, 1990. Regulation: 8.