PORTABLE X-RAY SYSTEM, MODEL PORT-X II

PORTABLE X-RAY SYSTEM, MODEL PORT-X II is an FDA 510(k)-cleared medical device (K063121) manufactured by Genoray Co., Ltd.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 10, 2007. Regulation: 8.