STANDARD BREAST BOARDS; DELUXE BREAST BOARD

STANDARD BREAST BOARDS; DELUXE BREAST BOARD is an FDA 510(k)-cleared medical device (K905007) manufactured by Bionix Development 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 February 11, 1991. Regulation: 8.