510(k) K203159

Lux 35 Detector by Carestream Health — Product Code MQB

K203159 is an FDA 510(k) premarket notification submitted by Carestream Health for the device "Lux 35 Detector". The FDA issued a decision of Substantially Equivalent on December 2, 2020. 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. Carestream Health has at least 10 other 510(k) clearances on record.