ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM

ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM is an FDA 510(k)-cleared medical device (K912416) manufactured by Xre Corp.. 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 27, 1991. Regulation: 8.