510(k) K181404

Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator by Varian Medical Systems, Inc. — Product Code IYE

K181404 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator". The FDA issued a decision of Substantially Equivalent on Jun 28, 2018. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Varian Medical Systems, Inc. has 205 other 510(k) clearances on record.