OLDELFT THORASCAN MODEL NUMBER 180T

OLDELFT THORASCAN MODEL NUMBER 180T is an FDA 510(k)-cleared medical device (K012165) manufactured by Nucletron 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 September 18, 2001. Regulation: 8.