DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC

DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC is an FDA 510(k)-cleared medical device (K140445) manufactured by Imaging Sciences International, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 22, 2014. Regulation: 8.