OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR

OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR is an FDA 510(k)-cleared medical device (K881665) manufactured by Omnitron Intl., 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 August 10, 1988. Regulation: 8.