510(k) K990085

MILLENNIUM MLC -120 by Varian Assoc., Inc. — Product Code IYE

K990085 is an FDA 510(k) premarket notification submitted by Varian Assoc., Inc. for the device "MILLENNIUM MLC -120". The FDA issued a decision of Substantially Equivalent on February 8, 1999. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Varian Assoc., Inc. has at least 10 other 510(k) clearances on record.