510(k) K031872

ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING] by Adac Laboratories — Product Code KPS

K031872 is an FDA 510(k) premarket notification submitted by Adac Laboratories for the device "ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING]". The FDA issued a decision of Substantially Equivalent on June 20, 2003. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Adac Laboratories has at least 10 other 510(k) clearances on record.