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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 a medical device manufactured by Cosmo Artificial Intelligence - Ai, Ltd.. It received FDA 510(k) clearance on 2023-05-19 under approval 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. It is manufactured by Cosmo Artificial Intelligence - Ai, Ltd.. The 510(k) number is K231143.

When was GI Genius System 100 and GI Genius System 200 approved by the FDA?

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

What company makes GI Genius System 100 and GI Genius System 200?

GI Genius System 100 and GI Genius System 200 is manufactured by Cosmo Artificial Intelligence - Ai, Ltd..

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.

Related Clinical Trials

NCT06385379 Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study) RECRUITING

Other Devices by Cosmo Artificial Intelligence - Ai, Ltd.

K211951GI Genius DEN200055GI Genius 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)

Related Devices (Code: QNP)

K211326EndoScreenerChengdu Wision Medical Device Co., Ltd. K211951GI GeniusCosmo Artificial Intelligence - Ai, Ltd. DEN200055GI GeniusCosmo Artificial Intelligence - Ai, Ltd. K213686SKOUT SoftwareIterative Scopes, Inc. K230751EW10-EC02 Endoscopy Support ProgramFujifilm Corporation K223473ME-APDS™; MAGENTIQ-COLO™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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