510(k) K231833

Biograph Vision.X and Biograph Vision.X Edge by Siemens Medical Solutions USA, Inc. — Product Code KPS

K231833 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "Biograph Vision.X and Biograph Vision.X Edge". The FDA issued a decision of Substantially Equivalent on July 13, 2023. 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.