510(k) K161061

IMPAX Volume Viewing 4.0 by Agfa Healthcare N.V. — Product Code LLZ

K161061 is an FDA 510(k) premarket notification submitted by Agfa Healthcare N.V. for the device "IMPAX Volume Viewing 4.0". The FDA issued a decision of Substantially Equivalent on Jun 22, 2016. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Agfa Healthcare N.V. has at least 10 other 510(k) clearances on record.