510(k) K253499

Ascent3T Neonatal Magnetic Resonance Imaging System by Eyas Medical Imaging, Inc. — Product Code LNH

K253499 is an FDA 510(k) premarket notification submitted by Eyas Medical Imaging, Inc. for the device "Ascent3T Neonatal Magnetic Resonance Imaging System". The FDA issued a decision of Substantially Equivalent on Jan 26, 2026. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000.