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FDA 510(k)

Ascent3T Neonatal Magnetic Resonance Imaging System

K-Number: K253499 · 2026-01-26

ApplicantEyas Medical Imaging, Inc.
Decision Date2026-01-26
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ascent3T Neonatal Magnetic Resonance Imaging System is a medical device manufactured by Eyas Medical Imaging, Inc.. It received FDA 510(k) clearance on 2026-01-26 under approval number K253499. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ascent3T Neonatal Magnetic Resonance Imaging System?

Ascent3T Neonatal Magnetic Resonance Imaging System is a medical device that received FDA 510(k) clearance on 2026-01-26. It is manufactured by Eyas Medical Imaging, Inc.. The 510(k) number is K253499.

When was Ascent3T Neonatal Magnetic Resonance Imaging System approved by the FDA?

Ascent3T Neonatal Magnetic Resonance Imaging System received FDA 510(k) clearance on 2026-01-26, under approval number K253499.

What company makes Ascent3T Neonatal Magnetic Resonance Imaging System?

Ascent3T Neonatal Magnetic Resonance Imaging System is manufactured by Eyas Medical Imaging, Inc..

What is the FDA product code for Ascent3T Neonatal Magnetic Resonance Imaging System?

The FDA product code for Ascent3T Neonatal Magnetic Resonance Imaging System is LNH.

Related Clinical Trials

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Related PubMed Literature

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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