“Tech-Image” 電子內視鏡系統
K 號：K260414 · 2026-06-10
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器材摘要
“Tech-Image” Video Endoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Image CO., LTD.. It received FDA 510(k) clearance on 2026-06-10 under 510(k) number K260414. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the “Tech-Image” Video Endoscope System?
“Tech-Image” Video Endoscope System is a medical device that received FDA 510(k) clearance on 2026-06-10. The listed applicant is Tech-Image CO., LTD.. The 510(k) number is K260414.
When did “Tech-Image” Video Endoscope System receive FDA 510(k) clearance?
“Tech-Image” Video Endoscope System received FDA 510(k) clearance on 2026-06-10, under 510(k) number K260414.
Who is the listed applicant for “Tech-Image” Video Endoscope System?
The FDA 510(k) record lists Tech-Image CO., LTD. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for “Tech-Image” Video Endoscope System?
The FDA product code for “Tech-Image” Video Endoscope System is GCJ.
相關臨床試驗
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相關器械（代碼：GCJ）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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