510(k) K051932

ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 by Elekta, Inc. — Product Code IYE

K051932 is an FDA 510(k) premarket notification submitted by Elekta, Inc. for the device "ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5". The FDA issued a decision of Substantially Equivalent on August 12, 2005. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Elekta, Inc. has at least 10 other 510(k) clearances on record.