510(k) K061540

LEKSELL GAMMAPLAN by Elekta Instrument AB — Product Code IWB

K061540 is an FDA 510(k) premarket notification submitted by Elekta Instrument AB for the device "LEKSELL GAMMAPLAN". The FDA issued a decision of Substantially Equivalent on July 5, 2006. The device falls under product code IWB (System, Radiation Therapy, Radionuclide), a Class II device regulated under 21 CFR 892.5750. Elekta Instrument AB has at least 10 other 510(k) clearances on record.