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Ascent3T Neonatal Magnetic Resonance Imaging System — Eyas Medical Imaging, Inc. (510(k) K253499)

Ascent3T Neonatal Magnetic Resonance Imaging System — Eyas Medical Imaging, Inc. (510(k) K253499) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Ascent3T Neonatal Magnetic Resonance Imaging System; Applicant: Eyas Medical Imaging, Inc.; Clearance track: 510(k).

Device nameAscent3T Neonatal Magnetic Resonance Imaging System
ApplicantEyas Medical Imaging, Inc.
Clearance track510(k)
Submission numberK253499
DecisionSubstantially Equivalent
Decision date2026-01-26
Date received2025-10-29
Product codeLNH
Device class2
Medical specialtyRadiology
Applicant locationOH, US
SourceopenFDA device

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