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FDA 510(k)

VISERA ELITE III 视频系统中心 OLYMPUS OTV-S700；VISERA ELITE III LED 灯源 OLYMPUS CLL-S700；4K 摄像头 OLYMPUS CH-S700-XZ-EA

K号: K242067 · 2025-04-02

申请人Olympus Corporations of the Americas
决定日期2025-04-02
产品代码FET
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

VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corporations of the Americas. It received FDA 510(k) clearance on 2025-04-02 under 510(k) number K242067. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA?

VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is a medical device that received FDA 510(k) clearance on 2025-04-02. The listed applicant is Olympus Corporations of the Americas. The 510(k) number is K242067.

When did VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA receive FDA 510(k) clearance?

VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA received FDA 510(k) clearance on 2025-04-02, under 510(k) number K242067.

Who is the listed applicant for VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA?

The FDA 510(k) record lists Olympus Corporations of the Americas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA?

The FDA product code for VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is FET.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：FET）

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。

K2620794K摄像头头 OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.K261880FUJIFILM 处理器 EP-8000；球囊控制器 PB-30；内窥镜支持程序 EW10-VM01Fujifilm CorporationK261260HD 摄像头 OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee视频处理单元（PV-003）Proverum LimitedK250462UL UHD-Clear View 4K摄像头系统（UL-3Chip 4K）Univlabs Technologies Private LimitedK250204内窥镜摄像头系统Shenzhen Sophway Technology Co., Ltd.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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