Halcyon, Ethos Radiotherapy System (5.0)

Halcyon, Ethos Radiotherapy System (5.0) is an FDA 510(k)-cleared medical device (K252977) 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 20, 2026. Regulation: 8.