510(k) K042334

ALLURA 3D-CA, RELEASE 1 by Philips Medical Systems North America Co. — Product Code LLZ

K042334 is an FDA 510(k) premarket notification submitted by Philips Medical Systems North America Co. for the device "ALLURA 3D-CA, RELEASE 1". The FDA issued a decision of Substantially Equivalent on September 27, 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 Co. has at least 10 other 510(k) clearances on record.