OPAL CHIRO, 20/20 P-DR

OPAL CHIRO, 20/20 P-DR is an FDA 510(k)-cleared medical device (K141435) manufactured by 2020 Imaging. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 26, 2014. Regulation: 8.