IR-192 IMPLANT, MODIFICATION

IR-192 IMPLANT, MODIFICATION is an FDA 510(k)-cleared medical device (K915253) 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 February 26, 1992. Regulation: 8.