SIS System (Version 5.1.0)

SIS System (Version 5.1.0) is an FDA 510(k)-cleared medical device (K210071) manufactured by Surgical Information Sciences, 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 March 30, 2021. Regulation: 8.