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FDA 510(k)

GI Genius System 100 and GI Genius System 200

K-Number: K231143 · 2023-05-19

ApplicantCosmo Artificial Intelligence - Ai, Ltd.
Decision Date2023-05-19
Product CodeQNP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Cosmo Artificial Intelligence - Ai, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261369GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)K241887GI 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)K233964GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)K211951GI Genius

Related Devices (Code: QNP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260567EW10-EC02 Endoscopy Support ProgramFujifilm CorporationK252853CAD - Lower GI (EC07-01)Xiamen Inno Medical Technology Co., Ltd.K261369GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)Cosmo Artificial Intelligence - Ai, Ltd.K260724MAGENTIQ-COLO (ME-APDS)Magentiq Eye, Ltd.K253664SKOUT systemIterative HealthK252178MAGENTIQ-COLO (ME-APDS)Magentiq Eye, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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