TELERADPRO EDGE; TELERADPRO EDGE HD-CCD

TELERADPRO EDGE; TELERADPRO EDGE HD-CCD is an FDA 510(k)-cleared medical device (K130636) manufactured by Vidar Systems Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 6, 2013. Regulation: 8.