GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM

GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM is an FDA 510(k)-cleared medical device (K983436) manufactured by Gammamed USA. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 28, 1998. Regulation: 8.