510(k) K241898

Symbia SPECT and SPECT/CT Systems by Siemens Healthineers — Product Code KPS

K241898 is an FDA 510(k) premarket notification submitted by Siemens Healthineers for the device "Symbia SPECT and SPECT/CT Systems". The FDA issued a decision of Substantially Equivalent on July 26, 2024. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Siemens Healthineers has at least 6 other 510(k) clearances on record.