510(k) K031597

DUNLEE FORMAT COLLIMATOR FAMILY by Philips Medical Systems North America Co. — Product Code IZW

K031597 is an FDA 510(k) premarket notification submitted by Philips Medical Systems North America Co. for the device "DUNLEE FORMAT COLLIMATOR FAMILY". The FDA issued a decision of Substantially Equivalent on July 21, 2003. The device falls under product code IZW (Collimator, Automatic, Radiographic), a Class II device regulated under 21 CFR 892.1610. Philips Medical Systems North America Co. has at least 10 other 510(k) clearances on record.