Axxent Electronic Brachytherapy System Model 110 XP 1200

Axxent Electronic Brachytherapy System Model 110 XP 1200 is an FDA 510(k)-cleared medical device (K153570) manufactured by Icad, 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 February 24, 2016. Regulation: 8.