GAMMAMED IRIDIUM-192 SOURCE

GAMMAMED IRIDIUM-192 SOURCE is an FDA 510(k)-cleared medical device (K894381) manufactured by Mick Radio-Nuclear Instruments, 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 November 20, 1989. Regulation: 8.