510(k) K162573

Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source by Source Production and Equipment Co., Inc. — Product Code KXK

K162573 is an FDA 510(k) premarket notification submitted by Source Production and Equipment Co., Inc. for the device "Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source". The FDA issued a decision of Substantially Equivalent on November 4, 2016. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Source Production and Equipment Co., Inc. has at least 6 other 510(k) clearances on record.