510(k) K050692

FLXIS by Philips Medical Systems North America Co. — Product Code JAA

K050692 is an FDA 510(k) premarket notification submitted by Philips Medical Systems North America Co. for the device "FLXIS". The FDA issued a decision of Substantially Equivalent on April 8, 2005. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), 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.