510(k) K090972

LEKSELL GAMMAPLAN by Elekta Instrument AB — Product Code MUJ

K090972 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 20, 2009. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Elekta Instrument AB has at least 10 other 510(k) clearances on record.