510(k) K111973

VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET by Nucletron — Product Code JAQ

K111973 is an FDA 510(k) premarket notification submitted by Nucletron for the device "VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET". The FDA issued a decision of Substantially Equivalent on September 21, 2011. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Nucletron has at least 10 other 510(k) clearances on record.