I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401

I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401 is an FDA 510(k)-cleared medical device (K992963) manufactured by International Isotopes, Inc.. 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 20, 1999. Regulation: 8.