IIRAD DIRECTRAY OPERATOR CONSOLE

IIRAD DIRECTRAY OPERATOR CONSOLE is an FDA 510(k)-cleared medical device (K980970) manufactured by Sterling Diagnostic Imaging, Inc.. 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 7, 1998. Regulation: 8.