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FDA 510(k)

Ascent3T 新生儿磁共振成像系统

K号: K253499 · 2026-01-26

决定日期2026-01-26
产品代码LNH
咨询委员会RA
决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

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相关器械(代码:LNH)

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