510(k) K091154

UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330, by Nucletron Corporation — Product Code JAQ

K091154 is an FDA 510(k) premarket notification submitted by Nucletron Corporation for the device "UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330,". The FDA issued a decision of Substantially Equivalent on May 18, 2009. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Nucletron Corporation has at least 10 other 510(k) clearances on record.