Ascent3T Neonatal Magnetic Resonance Imaging System

Ascent3T Neonatal Magnetic Resonance Imaging System is an FDA 510(k)-cleared medical device (K253499) manufactured by Eyas Medical Imaging, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 25, 2026. Regulation: 8.