510(k) K092804

MICROSELECTRON HDR V2, MODEL 105.999 by Nucletron Corp. — Product Code JAQ

K092804 is an FDA 510(k) premarket notification submitted by Nucletron Corp. for the device "MICROSELECTRON HDR V2, MODEL 105.999". The FDA issued a decision of Substantially Equivalent on October 8, 2009. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Nucletron Corp. has at least 10 other 510(k) clearances on record.