510(k) K041949

ALLURA XPER FD10 by Philips Medical Systems North America Co. — Product Code IZI

K041949 is an FDA 510(k) premarket notification submitted by Philips Medical Systems North America Co. for the device "ALLURA XPER FD10". The FDA issued a decision of Substantially Equivalent on July 30, 2004. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Philips Medical Systems North America Co. has at least 10 other 510(k) clearances on record.