510(k) K050151

MULTIDIAGNOST ELEVA by Philips Medical Systems North America, Inc. — Product Code KPR

K050151 is an FDA 510(k) premarket notification submitted by Philips Medical Systems North America, Inc. for the device "MULTIDIAGNOST ELEVA". The FDA issued a decision of Substantially Equivalent on February 9, 2005. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Philips Medical Systems North America, Inc. has at least 10 other 510(k) clearances on record.