510(k) K062298

APOLLO GAMMA CAMERA SYSTEM by Adac Laboratories — Product Code KPS

K062298 is an FDA 510(k) premarket notification submitted by Adac Laboratories for the device "APOLLO GAMMA CAMERA SYSTEM". The FDA issued a decision of Substantially Equivalent on August 23, 2006. 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.