FDA 510(k)

“Tech-Image” 视频内窥镜系统

K号: K260414 · 2026-06-10

决定日期2026-06-10

产品代码GCJ

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

“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.

常见问题

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.

相关器械（代码：GCJ）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE选择系统Karl Storz SE & CO. KG K260972OEV-271MUH 液晶显示器；OEV-321MUH 液晶显示器；OEV-431MUH 液晶显示器Sony Corporation K261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）Freyja Healthcare, LLC K253541EZ-Close™（EZ Close 端口部位闭合装置，EZ Close MAX 端口部位闭合装置，EZ Close II 端口部位闭合装置）Medical Impact K261614LED液晶显示器（OEV-271H）Lg Electronics.Inc

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器械摘要

常见问题

相关临床试验

相关器械（代码：GCJ）

官方来源