SMD-Sr90-DA Radionuclide Brachytherapy Source

SMD-Sr90-DA Radionuclide Brachytherapy Source is an FDA 510(k)-cleared medical device (K163206) manufactured by Salutaris Medical Devices, 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 December 14, 2016. Regulation: 8.