510(k) K243900

eMotus Respiratory Motion Management System by Empnia, Inc. — Product Code LHN

K243900 is an FDA 510(k) premarket notification submitted by Empnia, Inc. for the device "eMotus Respiratory Motion Management System". The FDA issued a decision of Substantially Equivalent on June 27, 2025. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050.