FDA 510(k)

擁抱新生兒MRI系統

K 號：K254277 · 2026-03-13

決定日期2026-03-13

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

Embrace Neonatal MRI System is the device name listed in this FDA 510(k) record. The listed applicant is Aspect Imaging, Ltd.. It received FDA 510(k) clearance on 2026-03-13 under 510(k) number K254277. 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 Embrace Neonatal MRI System?

Embrace Neonatal MRI System is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Aspect Imaging, Ltd.. The 510(k) number is K254277.

When did Embrace Neonatal MRI System receive FDA 510(k) clearance?

Embrace Neonatal MRI System received FDA 510(k) clearance on 2026-03-13, under 510(k) number K254277.

Who is the listed applicant for Embrace Neonatal MRI System?

FDA 510(k) 記錄將 Aspect Imaging, Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Embrace Neonatal MRI System?

The FDA product code for Embrace Neonatal MRI System is LNH.

其他以 Aspect Imaging, Ltd. 為申請人之記錄

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。

K261758擁抱視覺新生兒MRI系統 K170978擁抱新生兒MRI系統 K160185手環3

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。

K261283APERTO Lucent MRI 系統Fujifilm Corporation K261758擁抱視覺新生兒MRI系統Aspect Imaging, Ltd.K260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.K262622Swoop® 輕便式磁共振成像® 系統Hyperfine, Inc.K254250MagicScan-1.5，綠色MR寧靜1.5TXingaoyi Medical Equipment Co.,Ltd K253808空氣偵探 DLGE Medical Systems

官方來源

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