FDA 510(k)

ECHELON 協奏曲 MRI 系統

K 號：K241429 · 2024-08-13

決定日期2024-08-13

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

ECHELON Synergy MRI System is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Healthcare Corporation. It received FDA 510(k) clearance on 2024-08-13 under 510(k) number K241429. 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 ECHELON Synergy MRI System?

ECHELON Synergy MRI System is a medical device that received FDA 510(k) clearance on 2024-08-13. The listed applicant is Fujifilm Healthcare Corporation. The 510(k) number is K241429.

When did ECHELON Synergy MRI System receive FDA 510(k) clearance?

ECHELON Synergy MRI System received FDA 510(k) clearance on 2024-08-13, under 510(k) number K241429.

Who is the listed applicant for ECHELON Synergy MRI System?

The FDA 510(k) record lists Fujifilm Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECHELON Synergy MRI System?

The FDA product code for ECHELON Synergy MRI System is LNH.

其他以 Fujifilm Healthcare Corporation 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。

K240571OASIS MRI系統 K223426ECHELON Synergy MRI系統 K221619ECHELON 橢圓 V6.2 MRI 系統 K213829SCENARIA 觀察 K220295ARIETTA 50

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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