510(k) K011205

ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 by Isoaid — Product Code KXK

K011205 is an FDA 510(k) premarket notification submitted by Isoaid for the device "ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125". The FDA issued a decision of Substantially Equivalent on July 10, 2001. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Isoaid has at least 5 other 510(k) clearances on record.