VFSS IMAGER, MODEL SIS-300

VFSS IMAGER, MODEL SIS-300 is an FDA 510(k)-cleared medical device (K000987) manufactured by Lifecare Imaging Intl., Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 31, 2000. Regulation: 8.