DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA

DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA is an FDA 510(k)-cleared medical device (K123345) manufactured by Rayence 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 March 11, 2013. Regulation: 8.