SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM

SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K963952) manufactured by Ge Dec Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 22, 1996. Regulation: 8.