510(k) K160857

HF 718BD X-Ray System by Arquilla, Inc. Dba X-Cel X-Ray Corporation — Product Code KPR

K160857 is an FDA 510(k) premarket notification submitted by Arquilla, Inc. Dba X-Cel X-Ray Corporation for the device "HF 718BD X-Ray System". The FDA issued a decision of Substantially Equivalent on Feb 24, 2017. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680.