510(k) K022739

REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002 by Nucletron Corporation — Product Code JAQ

K022739 is an FDA 510(k) premarket notification submitted by Nucletron Corporation for the device "REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002". The FDA issued a decision of Substantially Equivalent on October 25, 2002. 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.