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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 the device name listed in this FDA 510(k) record. The listed applicant is Eyas Medical Imaging, Inc.. It received FDA 510(k) clearance on 2026-01-26 under 510(k) 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. The listed applicant is Eyas Medical Imaging, Inc.. The 510(k) number is K253499.

When did Ascent3T Neonatal Magnetic Resonance Imaging System receive FDA 510(k) clearance?

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

Who is the listed applicant for Ascent3T Neonatal Magnetic Resonance Imaging System?

The FDA 510(k) record lists Eyas Medical Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: LNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

Official Source

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

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