DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000

DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000 is an FDA 510(k)-cleared medical device (K092830) 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 July 20, 2010. Regulation: 8.