FDA 510(k)

4K內視鏡攝影系統 (SV-800, SV-800I, SV-800R, SV-800N)

K 號：K250551 · 2025-10-02

申請人Shenzhen Sophway Technology Co., Ltd.

決定日期2025-10-02

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Sophway Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-10-02 under 510(k) number K250551. 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 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)?

4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) is a medical device that received FDA 510(k) clearance on 2025-10-02. The listed applicant is Shenzhen Sophway Technology Co., Ltd.. The 510(k) number is K250551.

When did 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) receive FDA 510(k) clearance?

4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) received FDA 510(k) clearance on 2025-10-02, under 510(k) number K250551.

Who is the listed applicant for 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)?

The FDA 510(k) record lists Shenzhen Sophway Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)?

The FDA product code for 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) is GCJ.

其他以 Shenzhen Sophway Technology Co., Ltd. 為申請人之記錄

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K250204內視鏡攝影系統

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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