510(k) K011493

MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY by Mentor Corp. — Product Code KPT

K011493 is an FDA 510(k) premarket notification submitted by Mentor Corp. for the device "MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY". The FDA issued a decision of Substantially Equivalent on October 1, 2002. The device falls under product code KPT (Calibrator, Dose, Radionuclide), a Class II device regulated under 21 CFR 892.1360. Mentor Corp. has at least 10 other 510(k) clearances on record.