DIGITAL FLAT PANEL X-RAY DETECTOR

DIGITAL FLAT PANEL X-RAY DETECTOR is an FDA 510(k)-cleared medical device (K112558) manufactured by Samsung Mobile Display Co., Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 9, 2011. Regulation: 8.