NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A

NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A is an FDA 510(k)-cleared medical device (K972271) manufactured by Ml Strategies, 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 October 27, 1997. Regulation: 8.