AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033

AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033 is an FDA 510(k)-cleared medical device (K931883) manufactured by Alphatek 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 August 22, 1993. Regulation: 8.