510(k) K112670

DX-D 600 by Agfa Healthcare N.V. — Product Code KPR

K112670 is an FDA 510(k) premarket notification submitted by Agfa Healthcare N.V. for the device "DX-D 600". The FDA issued a decision of Substantially Equivalent on Oct 27, 2011. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Agfa Healthcare N.V. has at least 10 other 510(k) clearances on record.