AMCAD-UT DETECTION MODEL 2.0

AMCAD-UT DETECTION MODEL 2.0 is an FDA 510(k)-cleared medical device (K122536) manufactured by Lin & Associates, 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 October 2, 2013. Regulation: 8.