PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM

PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM is an FDA 510(k)-cleared medical device (K130088) 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 July 17, 2013. Regulation: 8.