860 COLOR DOPPLER OR COLORVIEW 860

860 COLOR DOPPLER OR COLORVIEW 860 is an FDA 510(k)-cleared medical device (K861538) manufactured by Ge Medical Systems Information Technologies. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 24, 1986. Regulation: 8.