510(k) K153056

Hermes Medical Imaging Suite v5.6 by Hermes Medical Solutions AB — Product Code KPS

K153056 is an FDA 510(k) premarket notification submitted by Hermes Medical Solutions AB for the device "Hermes Medical Imaging Suite v5.6". The FDA issued a decision of Substantially Equivalent on June 1, 2016. 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.