PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM is an FDA 510(k)-cleared medical device (K113672) manufactured by VATECH 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 March 26, 2012. Regulation: 8.