IMEX 8000 PERSONAL CASCULAR LAB

IMEX 8000 PERSONAL CASCULAR LAB is an FDA 510(k)-cleared medical device (K942243) manufactured by Imex Medical Systems, 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 November 2, 1995. Regulation: 8.