510(k) K102005

ALLURA XPER OR TABLE SERIES by Philips Medical Systems North America, Inc. — Product Code OWB

K102005 is an FDA 510(k) premarket notification submitted by Philips Medical Systems North America, Inc. for the device "ALLURA XPER OR TABLE SERIES". The FDA issued a decision of Substantially Equivalent on August 9, 2010. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Philips Medical Systems North America, Inc. has at least 10 other 510(k) clearances on record.