510(k) K954581

ARC SERIES by Continental X-Ray Corp. — Product Code IZI

K954581 is an FDA 510(k) premarket notification submitted by Continental X-Ray Corp. for the device "ARC SERIES". The FDA issued a decision of Substantially Equivalent on December 21, 1995. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Continental X-Ray Corp. has at least 10 other 510(k) clearances on record.