510(k) K080934

VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET by Nucletron Corporation — Product Code JAQ

K080934 is an FDA 510(k) premarket notification submitted by Nucletron Corporation for the device "VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET". The FDA issued a decision of Substantially Equivalent on May 28, 2008. 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.