FDA 510(k)

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

K 號：K261880 · 2026-07-02

決定日期2026-07-02

產品代碼FET

諮詢委員會GU

決定相當於

器材摘要

FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K261880. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01?

FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is Fujifilm Corporation. The 510(k) number is K261880.

When did FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 receive FDA 510(k) clearance?

FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 received FDA 510(k) clearance on 2026-07-02, under 510(k) number K261880.

Who is the listed applicant for FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01?

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 FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01?

The FDA product code for FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 is FET.

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 K253137富士通內視鏡型號 EB-840S；富士通內視鏡型號 EB-840T

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相關器械（代碼：FET）

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。

K2620794K攝影鏡頭 OLYMPUS CH-S700-08-LB 医療設備規範文本Olympus Medical Systems Corp.K261260HD攝影鏡頭 OLYMPUS CH-S200-08-LBOlympus Medical Systems Corporation K251734ProVee影片處理單元（PV-003）Proverum Limited K250462UL UHD-Clear View 4K攝影系統（UL-3Chip 4K）Univlabs Technologies Private Limited K250204內視鏡攝影系統Shenzhen Sophway Technology Co., Ltd.K243260富士通處理器EP-8000；富士通內視鏡型號EG-860RFujifilm Corporation

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