510(k) K101311

EP NAVIGATOR R3 by Philips Medical Systems North America Co. — Product Code LLZ

K101311 is an FDA 510(k) premarket notification submitted by Philips Medical Systems North America Co. for the device "EP NAVIGATOR R3". The FDA issued a decision of Substantially Equivalent on September 30, 2010. 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.