IBU, INTEGRATED BRACHY THERAPY UNIT

IBU, INTEGRATED BRACHY THERAPY UNIT is an FDA 510(k)-cleared medical device (K973848) 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 January 21, 1998. Regulation: 8.