PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000

PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000 is an FDA 510(k)-cleared medical device (K984092) manufactured by Trex Medical 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 4, 1999. Regulation: 8.