INTEGRATED BRACHYTHERAPY UNIT - DIGITAL

INTEGRATED BRACHYTHERAPY UNIT - DIGITAL is an FDA 510(k)-cleared medical device (K072445) manufactured by Nucletron 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 September 13, 2007. Regulation: 8.