BIOLUCENT MAMMOGRAPHY CUSHION

BIOLUCENT MAMMOGRAPHY CUSHION is an FDA 510(k)-cleared medical device (K003795) manufactured by Biolucent, 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 13, 2001. Regulation: 8.