510(k) K911078

MULTISPECT 3 TRIPLE DETECTOR CAMERA SYSTEM by Siemens Gammasonics, Inc. — Product Code KPS

K911078 is an FDA 510(k) premarket notification submitted by Siemens Gammasonics, Inc. for the device "MULTISPECT 3 TRIPLE DETECTOR CAMERA SYSTEM". The FDA issued a decision of Substantially Equivalent on June 17, 1991. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Siemens Gammasonics, Inc. has at least 10 other 510(k) clearances on record.