510(k) K210500

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD by Elekta Limited — Product Code IYE

K210500 is an FDA 510(k) premarket notification submitted by Elekta Limited for the device "Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD". The FDA issued a decision of Substantially Equivalent on June 11, 2021. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Elekta Limited has at least 7 other 510(k) clearances on record.