SPACEMISER 8-10 FILM RECORDER

SPACEMISER 8-10 FILM RECORDER is an FDA 510(k)-cleared medical device (K871957) manufactured by Frantz 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 21, 1987. Regulation: 8.