510(k) K251561

Biograph Trinion by Siemens Medical Solutions USA, Inc. — Product Code KPS

K251561 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "Biograph Trinion". The FDA issued a decision of Substantially Equivalent on July 31, 2025. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.