510(k) K991129

HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL by Hitachi Medical Corp. of America — Product Code KPS

K991129 is an FDA 510(k) premarket notification submitted by Hitachi Medical Corp. of America for the device "HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL". The FDA issued a decision of Substantially Equivalent on May 13, 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.