510(k) K051351

PRECEDENCE SPECT/CT IMAGING SYSTEM by Adac Laboratories — Product Code KPS

K051351 is an FDA 510(k) premarket notification submitted by Adac Laboratories for the device "PRECEDENCE SPECT/CT IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 8, 2005. 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.