510(k) K090590

VERADIUS, MODEL 718-130 by Philips Medical Systems North America Co. — Product Code OWB

K090590 is an FDA 510(k) premarket notification submitted by Philips Medical Systems North America Co. for the device "VERADIUS, MODEL 718-130". The FDA issued a decision of Substantially Equivalent on March 16, 2009. 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 Co. has at least 10 other 510(k) clearances on record.