510(k) K926449

VARIAN MULTILEAF COLLIMATOR, RELEASE 4.0 by Varian Assoc., Inc. — Product Code IYE

K926449 is an FDA 510(k) premarket notification submitted by Varian Assoc., Inc. for the device "VARIAN MULTILEAF COLLIMATOR, RELEASE 4.0". The FDA issued a decision of Substantially Equivalent on May 5, 1995. 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.