FDA 510(k)

1688 4K 鏡頭系統，具有先進影像技術；1788 4K 鏡頭系統，具有先進影像技術

K 號：K260185 · 2026-02-18

決定日期2026-02-18

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2026-02-18 under 510(k) number K260185. 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 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality?

1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality is a medical device that received FDA 510(k) clearance on 2026-02-18. The listed applicant is Stryker Endoscopy. The 510(k) number is K260185.

When did 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality receive FDA 510(k) clearance?

1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality received FDA 510(k) clearance on 2026-02-18, under 510(k) number K260185.

Who is the listed applicant for 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality?

FDA 510(k) 記錄將 Stryker Endoscopy 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality?

The FDA product code for 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality is GCJ.

其他以 Stryker Endoscopy 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。

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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

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