510(k) K954143

HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS by Hitachi Medical Corp. of America — Product Code KPS

K954143 is an FDA 510(k) premarket notification submitted by Hitachi Medical Corp. of America for the device "HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS". The FDA issued a decision of Substantially Equivalent on December 22, 1995. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Hitachi Medical Corp. of America has at least 10 other 510(k) clearances on record.