510(k) K063781

PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE by Philips Medical Systems North America Co. — Product Code LLZ

K063781 is an FDA 510(k) premarket notification submitted by Philips Medical Systems North America Co. for the device "PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE". The FDA issued a decision of Substantially Equivalent on January 5, 2007. 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 Co. has at least 10 other 510(k) clearances on record.