510(k) K183275

DR 800 with Tomosynthesis by Agfa N.V. — Product Code IZF

K183275 is an FDA 510(k) premarket notification submitted by Agfa N.V. for the device "DR 800 with Tomosynthesis". The FDA issued a decision of Substantially Equivalent on February 1, 2019. The device falls under product code IZF (System, X-Ray, Tomographic), a Class II device regulated under 21 CFR 892.1740. Agfa N.V. has at least 5 other 510(k) clearances on record.