510(k) K193262

DR 600 with Tomosynthesis by Agfa N.V. — Product Code IZF

K193262 is an FDA 510(k) premarket notification submitted by Agfa N.V. for the device "DR 600 with Tomosynthesis". The FDA issued a decision of Substantially Equivalent on March 9, 2020. 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.