THE DOME GX4MP COLOR NONITOR

THE DOME GX4MP COLOR NONITOR is an FDA 510(k)-cleared medical device (K120709) manufactured by Nds Surgical Imaging. 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 5, 2012. Regulation: 8.