FDA 510(k)

GI Genius 系统 100 和 GI Genius 系统 200

K号: K231143 · 2023-05-19

申请人Cosmo Artificial Intelligence - Ai, Ltd.

决定日期2023-05-19

产品代码QNP

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决定实质等同

器械摘要

GI Genius System 100 and GI Genius System 200 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 2023-05-19 under 510(k) number K231143. 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 System 100 and GI Genius System 200?

GI Genius System 100 and GI Genius System 200 is a medical device that received FDA 510(k) clearance on 2023-05-19. The listed applicant is Cosmo Artificial Intelligence - Ai, Ltd.. The 510(k) number is K231143.

When did GI Genius System 100 and GI Genius System 200 receive FDA 510(k) clearance?

GI Genius System 100 and GI Genius System 200 received FDA 510(k) clearance on 2023-05-19, under 510(k) number K231143.

Who is the listed applicant for GI Genius System 100 and GI Genius System 200?

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 System 100 and GI Genius System 200?

The FDA product code for GI Genius System 100 and GI Genius System 200 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。

K261369GI Genius™ 模块 300 (GGM300-US)；ColonPRO™ US (CPRO403S-US)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)K211951GI Genius

官方来源

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