510(k) K992963

I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401 by International Isotopes, Inc. — Product Code KXK

K992963 is an FDA 510(k) premarket notification submitted by International Isotopes, Inc. for the device "I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401". The FDA issued a decision of Substantially Equivalent on September 21, 1999. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. International Isotopes, Inc. has at least 1 other 510(k) clearance on record.