I-125 RAPID STRAND

I-125 RAPID STRAND is an FDA 510(k)-cleared medical device (K940632) 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 September 1, 1994. Regulation: 8.