510(k) K252911

Lux HD 2530 detector (Lux HD 2530) by Iray Imaging Technology (Haining) Limited — Product Code MQB

K252911 is an FDA 510(k) premarket notification submitted by Iray Imaging Technology (Haining) Limited for the device "Lux HD 2530 detector (Lux HD 2530)". The FDA issued a decision of Substantially Equivalent on October 9, 2025. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Iray Imaging Technology (Haining) Limited has at least 3 other 510(k) clearances on record.