510(k) K161368

DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) by Agfa Healthcare N.V. — Product Code MQB

K161368 is an FDA 510(k) premarket notification submitted by Agfa Healthcare N.V. for the device "DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)". The FDA issued a decision of Substantially Equivalent on Sep 22, 2016. 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 Healthcare N.V. has at least 10 other 510(k) clearances on record.