PROFILE MAMMOGRAPHY SYSTEM (M-PRO)

PROFILE MAMMOGRAPHY SYSTEM (M-PRO) is an FDA 510(k)-cleared medical device (K964576) manufactured by Bennett X-Ray 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 January 9, 1997. Regulation: 8.