510(k) K211790

DX-D Imaging Package with XD Detectors by Agfa N.V. — Product Code MQB

K211790 is an FDA 510(k) premarket notification submitted by Agfa N.V. for the device "DX-D Imaging Package with XD Detectors". The FDA issued a decision of Substantially Equivalent on July 30, 2021. 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. Agfa N.V. has at least 5 other 510(k) clearances on record.