I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]

I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] is an FDA 510(k)-cleared medical device (K141701) 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 December 4, 2014. Regulation: 8.