510(k) K212145

DR 800 with DSA, DR 800 by Agfa N.V. — Product Code JAA

K212145 is an FDA 510(k) premarket notification submitted by Agfa N.V. for the device "DR 800 with DSA, DR 800". The FDA issued a decision of Substantially Equivalent on August 31, 2021. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Agfa N.V. has at least 5 other 510(k) clearances on record.