DIGITAL FLAT PANEL X-RAY DETECTOR

DIGITAL FLAT PANEL X-RAY DETECTOR is an FDA 510(k)-cleared medical device (K101590) manufactured by VATECH 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 28, 2010. Regulation: 8.