System, Applicator, Radionuclide, Remote Controlled

System, Applicator, Radionuclide, Remote Controlled is an FDA 510(k)-cleared medical device (K170203) manufactured by Kobold, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 31, 2017. Regulation: 8.