PRONE BREAST POSITIONING BOARD, MODEL #37-018

PRONE BREAST POSITIONING BOARD, MODEL #37-018 is an FDA 510(k)-cleared medical device (K971382) manufactured by Victoreen, 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 June 5, 1997. Regulation: 8.