SERIES 7600 MOBILE DIGITAL C-ARM

SERIES 7600 MOBILE DIGITAL C-ARM is an FDA 510(k)-cleared medical device (K970063) 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 March 10, 1997. Regulation: 8.