510(k) K233677

Biograph VK10 by Siemens Medical Solutions USA, Inc. — Product Code KPS

K233677 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "Biograph VK10". The FDA issued a decision of Substantially Equivalent on January 12, 2024. 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.