AX-700LE AUTOMATIC X-RAY FILM PROCESSOR

AX-700LE AUTOMATIC X-RAY FILM PROCESSOR is an FDA 510(k)-cleared medical device (K925569) 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 January 14, 1993. Regulation: 8.