RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE

RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE is an FDA 510(k)-cleared medical device (K120344) manufactured by Radiadyne, LLC (Specification Developer). This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 2, 2012. Regulation: 8.