PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)

PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO) is an FDA 510(k)-cleared medical device (K141497) manufactured by Osstem Implant 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 August 25, 2014. Regulation: 8.