AUTIMO 2.5-D AND AUTIMO 3-D

AUTIMO 2.5-D AND AUTIMO 3-D is an FDA 510(k)-cleared medical device (K972016) manufactured by C.L. Mcintosh & Assoc., 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 December 3, 1997. Regulation: 8.