AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027

AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027 is an FDA 510(k)-cleared medical device (K924430) 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 November 26, 1992. Regulation: 8.