510(k) K913630

MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM by Siemens Gammasonics, Inc. — Product Code KPS

K913630 is an FDA 510(k) premarket notification submitted by Siemens Gammasonics, Inc. for the device "MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM". The FDA issued a decision of Substantially Equivalent on October 23, 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.