MEDRAD FLUOROVISION HR 2000, HIGH RESOLUTION IMAGE

MEDRAD FLUOROVISION HR 2000, HIGH RESOLUTION IMAGE is an FDA 510(k)-cleared medical device (K900586) manufactured by Medrad, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 22, 1990. Regulation: 8.