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FDA 510(k)

GI Genius™ 模块 100 (GGM100.US)；GI Genius™ 模块 200 (GGM200.US)；ColonPRO™ 4.0 (CPRO40.US)；GI Genius™ 模块 300 (GGM300-US)；ColonPRO™ 4.0 (CPRO40S-US)

K号: K241887 · 2024-07-25

申请人Cosmo Artificial Intelligence - Ai, Ltd.
决定日期2024-07-25
产品代码QNP
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

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US) is the device name listed in this FDA 510(k) record. The listed applicant is Cosmo Artificial Intelligence - Ai, Ltd.. It received FDA 510(k) clearance on 2024-07-25 under 510(k) number K241887. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)?

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US) is a medical device that received FDA 510(k) clearance on 2024-07-25. The listed applicant is Cosmo Artificial Intelligence - Ai, Ltd.. The 510(k) number is K241887.

When did GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US) receive FDA 510(k) clearance?

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US) received FDA 510(k) clearance on 2024-07-25, under 510(k) number K241887.

Who is the listed applicant for GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)?

The FDA 510(k) record lists Cosmo Artificial Intelligence - Ai, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)?

The FDA product code for GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US) is QNP.

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

列明Cosmo Artificial Intelligence - Ai, Ltd.为申报人的其他记录

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。

K261369GI Genius™ 模块 300 (GGM300-US)；ColonPRO™ US (CPRO403S-US)K233964GI Genius™ 模块 100 (GGM100.US)；GI Genius™ 模块 200 (GGM200.US)；ColonPRO™ 4.0 (CPRO40.US)K231143GI Genius 系统 100 和 GI Genius 系统 200K211951GI Genius

相关器械（代码：QNP）

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。

K260133CADDIEOdin Medical LimitedK260567EW10-EC02 内窥镜支持程序Fujifilm CorporationK252853CAD - 下消化道（EC07-01）Xiamen Inno Medical Technology Co., Ltd.K261369GI Genius™ 模块 300 (GGM300-US)；ColonPRO™ US (CPRO403S-US)Cosmo Artificial Intelligence - Ai, Ltd.K260724MAGENTIQ-COLO (ME-APDS)Magentiq Eye, Ltd.K253664SKOUT 系统Iterative Health

官方来源

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