DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16

DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16 is an FDA 510(k)-cleared medical device (K080553) manufactured by Vieworks 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 April 15, 2008. Regulation: 8.