510(k) K121278

HERMES MEDICAL IMAGING SUITE V5.2 by Hermes Medical Solutions AB — Product Code KPS

K121278 is an FDA 510(k) premarket notification submitted by Hermes Medical Solutions AB for the device "HERMES MEDICAL IMAGING SUITE V5.2". The FDA issued a decision of Substantially Equivalent on December 18, 2012. 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.