QCT-LUNG NODULE (TM) ANALYSIS PACKAGE

QCT-LUNG NODULE (TM) ANALYSIS PACKAGE is an FDA 510(k)-cleared medical device (K891931) manufactured by Image Analysis, 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 May 17, 1989. Regulation: 8.