510(k) K092083

EXTEND FRAME SYSTEM, MODEL 1009633 by Elekta Instrument AB — Product Code IWB

K092083 is an FDA 510(k) premarket notification submitted by Elekta Instrument AB for the device "EXTEND FRAME SYSTEM, MODEL 1009633". The FDA issued a decision of Substantially Equivalent on September 22, 2009. 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.