510(k) K173381

Nexxis OR by Barco N.V. — Product Code DXJ

K173381 is an FDA 510(k) premarket notification submitted by Barco N.V. for the device "Nexxis OR". The FDA issued a decision of Substantially Equivalent on February 22, 2018. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. Barco N.V. has at least 10 other 510(k) clearances on record.