X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC

X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC is an FDA 510(k)-cleared medical device (K770693) manufactured by Xonics Medical Systems, 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 August 2, 1977. Regulation: 8.