CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN

CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN is an FDA 510(k)-cleared medical device (K900448) manufactured by E.I. Dupont DE Nemours & Co., Inc.. This device is classified under the Radiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 15, 1990. Regulation: 8.