FILMSAVER, NT VERSION 5.03

FILMSAVER, NT VERSION 5.03 is an FDA 510(k)-cleared medical device (K021072) manufactured by American Medical Resources, Ltd. (Amr). 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 5, 2002. Regulation: 8.