ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501

ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 is an FDA 510(k)-cleared medical device (K991526) manufactured by Imagyn Medical Technologies, 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 June 16, 1999. Regulation: 8.