510(k) K243556

Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) by Iray Imaging Technology (Haining) Limited — Product Code MQB

K243556 is an FDA 510(k) premarket notification submitted by Iray Imaging Technology (Haining) Limited for the device "Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)". The FDA issued a decision of Substantially Equivalent on March 18, 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.