IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS.

IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS. is an FDA 510(k)-cleared medical device (K813544) manufactured by Irex Corp.. 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 4, 1982. Regulation: 8.