SIS System (Version 5.6.0)

SIS System (Version 5.6.0) is an FDA 510(k)-cleared medical device (K223032) 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 November 20, 2022. Regulation: 8.