Respiratory Gating for Scanners v2.0

Respiratory Gating for Scanners v2.0 is an FDA 510(k)-cleared medical device (K213927) manufactured by Varian Medical Systems, 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 January 13, 2022. Regulation: 8.