CARESTREAM DRYVIEW 5850 LASER IMAGER

CARESTREAM DRYVIEW 5850 LASER IMAGER is an FDA 510(k)-cleared medical device (K090469) manufactured by Carestream Health, 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 May 21, 2009. Regulation: 8.