105MM ROLL FILM FLUOROGR. CAMERA, #105

105MM ROLL FILM FLUOROGR. CAMERA, #105 is an FDA 510(k)-cleared medical device (K810072) manufactured by Scientex Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 11, 1981. Regulation: 8.