SUINSA DIAGNOSTIC X-RAY SYSTEM

SUINSA DIAGNOSTIC X-RAY SYSTEM is an FDA 510(k)-cleared medical device (K083109) manufactured by Suinsa. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 3, 2008. Regulation: 8.