I-125 SEEDS, CODE: 6711

I-125 SEEDS, CODE: 6711 is an FDA 510(k)-cleared medical device (K914281) manufactured by Medi-Physics Inc. Dba Nycomed Amersham Imaging. 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 21, 1991. Regulation: 8.