510(k) K150979

CT/MR Compatible M.A.C. Interstitial GYN Template by Mick Radio-Nuclear Instruments, Inc. — Product Code JAQ

K150979 is an FDA 510(k) premarket notification submitted by Mick Radio-Nuclear Instruments, Inc. for the device "CT/MR Compatible M.A.C. Interstitial GYN Template". The FDA issued a decision of Substantially Equivalent on May 31, 2016. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Mick Radio-Nuclear Instruments, Inc. has at least 10 other 510(k) clearances on record.