510(k) K180589

DR 800 with MUSICA Dynamic by Agfa Healthcare N.V. — Product Code JAA

K180589 is an FDA 510(k) premarket notification submitted by Agfa Healthcare N.V. for the device "DR 800 with MUSICA Dynamic". The FDA issued a decision of Substantially Equivalent on Apr 5, 2018. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Agfa Healthcare N.V. has at least 10 other 510(k) clearances on record.