SYNGO, CT LIVER ANALYSIS

SYNGO, CT LIVER ANALYSIS is an FDA 510(k)-cleared medical device (K133643) manufactured by Siemens Medi Cal Solutions, 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 November 12, 2014. Regulation: 8.