FDA 510(k)

GI Genius™ 模块 300 (GGM300-US)；ColonPRO™ US (CPRO403S-US)

K号: K261369 · 2026-05-29

申请人Cosmo Artificial Intelligence - Ai, Ltd.

决定日期2026-05-29

产品代码QNP

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决定实质等同

器械摘要

GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-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 2026-05-29 under 510(k) number K261369. 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 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)?

GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is Cosmo Artificial Intelligence - Ai, Ltd.. The 510(k) number is K261369.

When did GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) receive FDA 510(k) clearance?

GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) received FDA 510(k) clearance on 2026-05-29, under 510(k) number K261369.

Who is the listed applicant for GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-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 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)?

The FDA product code for GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) is QNP.

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。

K241887GI 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)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 200 K211951GI Genius

官方来源

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