MODEL 400 ULTRA COMPACT VIDEO IMAGER

MODEL 400 ULTRA COMPACT VIDEO IMAGER is an FDA 510(k)-cleared medical device (K904897) manufactured by International Imaging Electronics. 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 19, 1990. Regulation: 8.