510(k) K193238

Nexus DR Digital X-Ray Imaging System (with vSharp) by Varex Imaging Corporation — Product Code MQB

K193238 is an FDA 510(k) premarket notification submitted by Varex Imaging Corporation for the device "Nexus DR Digital X-Ray Imaging System (with vSharp)". The FDA issued a decision of Substantially Equivalent on December 20, 2019. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Varex Imaging Corporation has at least 6 other 510(k) clearances on record.