ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT

ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT is an FDA 510(k)-cleared medical device (K863710) manufactured by Ausonics Pty , Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 13, 1986. Regulation: 8.