510(k) K081036

4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS) by Varian Medical Systems, Inc. — Product Code IYE

K081036 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS)". The FDA issued a decision of Substantially Equivalent on May 9, 2008. 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 at least 10 other 510(k) clearances on record.