510(k) K991535

CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS by Hitachi Medical Corp. of America — Product Code KPS

K991535 is an FDA 510(k) premarket notification submitted by Hitachi Medical Corp. of America for the device "CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS". The FDA issued a decision of Substantially Equivalent on July 30, 1999. 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.