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Eastman Kodak Company
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KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976 is an FDA 510(k)-cleared medical device (K020635) 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 March 20, 2002. Regulation: 8.