510(k) K193152

Affinity by Hermes Medical Solutions AB — Product Code KPS

K193152 is an FDA 510(k) premarket notification submitted by Hermes Medical Solutions AB for the device "Affinity". The FDA issued a decision of Substantially Equivalent on February 14, 2020. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Hermes Medical Solutions AB has at least 10 other 510(k) clearances on record.