ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT

ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT is an FDA 510(k)-cleared medical device (K113210) manufactured by Isoaid, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 9, 2012. Regulation: 8.