DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA

DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA is an FDA 510(k)-cleared medical device (K133409) 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 February 20, 2014. Regulation: 8.