RefleXion Medical Radiotherapy System, Reflexion X2

RefleXion Medical Radiotherapy System, Reflexion X2 is an FDA 510(k)-cleared medical device (K252071) manufactured by Reflexion Medical, 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 December 17, 2025. Regulation: 8.