CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris

CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris is an FDA 510(k)-cleared medical device (K171353) manufactured by Minxray, 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 6, 2017. Regulation: 8.