Ascent3T 新生兒磁共振成像系統
K 號：K253499 · 2026-01-26
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器材摘要
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.
常見問題
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.
相關臨床試驗
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相關器械（代碼：LNH）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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