RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE

RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE is an FDA 510(k)-cleared medical device (K982862) manufactured by Applicare Medical Imaging, B.V.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 20, 1998. Regulation: 8.