510(k) K254001

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) by Spectrum Dynamics Medical, Ltd. — Product Code KPS

K254001 is an FDA 510(k) premarket notification submitted by Spectrum Dynamics Medical, Ltd. for the device "VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)". The FDA issued a decision of Substantially Equivalent on January 13, 2026. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Spectrum Dynamics Medical, Ltd. has at least 7 other 510(k) clearances on record.