UMI X-RAY FILM CASSETTE

UMI X-RAY FILM CASSETTE is an FDA 510(k)-cleared medical device (K971431) manufactured by Umi Intl.. 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 19, 1997. Regulation: 8.