I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE

I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE is an FDA 510(k)-cleared medical device (K023242) manufactured by Implant Sciences Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 3, 2002. Regulation: 8.