Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source

Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source is an FDA 510(k)-cleared medical device (K162573) manufactured by Source Production and Equipment Co., Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 3, 2016. Regulation: 8.