510(k) K042867

PHILIPS ORTHOPAEDIC APPLICATIONS by Philips Medical Systems North America, Inc. — Product Code LLZ

K042867 is an FDA 510(k) premarket notification submitted by Philips Medical Systems North America, Inc. for the device "PHILIPS ORTHOPAEDIC APPLICATIONS". The FDA issued a decision of Substantially Equivalent on November 2, 2004. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Philips Medical Systems North America, Inc. has at least 10 other 510(k) clearances on record.