FDA 510(k)

ECHELON 協奏曲

K 號：K251386 · 2025-09-17

決定日期2025-09-17

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

ECHELON Synergy is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2025-09-17 under 510(k) number K251386. 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?

ECHELON Synergy is a medical device that received FDA 510(k) clearance on 2025-09-17. The listed applicant is Fujifilm Corporation. The 510(k) number is K251386.

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

ECHELON Synergy received FDA 510(k) clearance on 2025-09-17, under 510(k) number K251386.

Who is the listed applicant for ECHELON Synergy?

FDA 510(k) 記錄中將富士通公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for ECHELON Synergy?

The FDA product code for ECHELON Synergy is LNH.

其他以 Fujifilm 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。

K261229SCENARIA 觀察階段 6.0 K261283APERTO Lucent MRI 系統 K253836FCT iStream 階段 2 K261170BA-004CC K260567EW10-EC02內視鏡輔助程序 K261880富士通電子處理器EP-8000；氣球控制器PB-30；內視鏡輔助程序EW10-VM01

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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。

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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