Low Dose CT Lung Cancer Screening Option for Qualified GE Systems

Low Dose CT Lung Cancer Screening Option for Qualified GE Systems is an FDA 510(k)-cleared medical device (K151372) manufactured by Ge Medical Systems, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 13, 2015. Regulation: 8.