DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION

DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION is an FDA 510(k)-cleared medical device (K950608) manufactured by Lorad 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 1, 1995. Regulation: 8.