CRONEX COMPACT MAMMOGRAPHY CASSETTE

CRONEX COMPACT MAMMOGRAPHY CASSETTE is an FDA 510(k)-cleared medical device (K895335) manufactured by E.I. Dupont DE Nemours & Co., 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 15, 1990. Regulation: 8.