KODAK M35A-M X-OMAT PROCESSOR

KODAK M35A-M X-OMAT PROCESSOR is an FDA 510(k)-cleared medical device (K901772) manufactured by Eastman Kodak Company. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 24, 1990. Regulation: 8.