10 CURIE IRDIUM 192, CSN00100-192

10 CURIE IRDIUM 192, CSN00100-192 is an FDA 510(k)-cleared medical device (K991571) manufactured by Alpha-Omega Services, 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 February 21, 2000. Regulation: 8.