DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE

DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE is an FDA 510(k)-cleared medical device (K863132) manufactured by General Electric Co.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 13, 1987. Regulation: 8.