MATRIX CR 2050, PMI 3000

MATRIX CR 2050, PMI 3000 is an FDA 510(k)-cleared medical device (K925289) manufactured by Heraeus Kulzer, 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 April 7, 1993. Regulation: 8.