TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION

TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION is an FDA 510(k)-cleared medical device (K131489) manufactured by Tractus Corporation. 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 24, 2013. Regulation: 8.