GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L

GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L is an FDA 510(k)-cleared medical device (K111434) manufactured by Giotto USA, 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 26, 2011. Regulation: 8.