PACSMATE, MODEL MMD-4300C/MMD-4300CX

PACSMATE, MODEL MMD-4300C/MMD-4300CX is an FDA 510(k)-cleared medical device (K091687) manufactured by Iei Technology 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 July 6, 2009. Regulation: 8.