510(k) K250954

DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector by Carestream Health — Product Code KPR

K250954 is an FDA 510(k) premarket notification submitted by Carestream Health for the device "DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector". The FDA issued a decision of Substantially Equivalent on January 20, 2026. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Carestream Health has at least 10 other 510(k) clearances on record.