HF 718BD X-Ray System

HF 718BD X-Ray System is an FDA 510(k)-cleared medical device (K160857) manufactured by Arquilla, Inc. Dba X-Cel X-Ray Corporation. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 23, 2017. Regulation: 8.