FDA 510(k)

富士通內視鏡型號 ED-S100TP；富士通內視鏡型號 ED-S100XP；富士通處理器型號 VS-1000

K 號：K251861 · 2026-03-09

決定日期2026-03-09

產品代碼FDT

諮詢委員會GU

決定相當於

器材摘要

FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2026-03-09 under 510(k) number K251861. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000?

FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 is a medical device that received FDA 510(k) clearance on 2026-03-09. The listed applicant is Fujifilm Corporation. The 510(k) number is K251861.

When did FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 receive FDA 510(k) clearance?

FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 received FDA 510(k) clearance on 2026-03-09, under 510(k) number K251861.

Who is the listed applicant for FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000?

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 Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000?

The FDA product code for FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 is FDT.

其他以 Fujifilm Corporation 為申請人之記錄

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相關器械（代碼：FDT）

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

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