ADC COMPACT (AGFA DIAGNOSTIC CENTER)

ADC COMPACT (AGFA DIAGNOSTIC CENTER) is an FDA 510(k)-cleared medical device (K974597) manufactured by Bayer Corp., Agfa Div.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 8, 1998. Regulation: 8.