510(k) K033770

ISOAID ADVANTAGE PD-103, MODEL IAPD-103A by Isoaid, LLC — Product Code KXK

K033770 is an FDA 510(k) premarket notification submitted by Isoaid, LLC for the device "ISOAID ADVANTAGE PD-103, MODEL IAPD-103A". The FDA issued a decision of Substantially Equivalent on April 8, 2004. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Isoaid, LLC has at least 5 other 510(k) clearances on record.