IR-192 IMPLANT -- MODIFICATION

IR-192 IMPLANT -- MODIFICATION is an FDA 510(k)-cleared medical device (K923130) 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 September 20, 1992. Regulation: 8.