AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM is an FDA 510(k)-cleared medical device (K050843) manufactured by Xoft, 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 December 21, 2005. Regulation: 8.