DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600

DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600 is an FDA 510(k)-cleared medical device (K093816) manufactured by Medien International Co, Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 4, 2010. Regulation: 8.