IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR

IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR is an FDA 510(k)-cleared medical device (K041380) manufactured by R2 Technology, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 7, 2004. Regulation: 8.