# Cosmo Artificial Intelligence - Ai, Ltd.

- Location (FDA's records): Dublin, IE
- FDA decisions: 6 (2021–2026): 5 510(k) clearances and 1 De Novo grant
- Product codes: QNP (6)
- 510(k) review time since 2016: median 28 days, against 85 for FDA's reviews in the same codes and years (4 of 4 faster)
- Predicates its devices cite: 5 (5 its own); citations of its devices by later devices: 12 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Xiamen Inno Medical Technology Co., Ltd.: 2 (https://510kreport.com/company/xiamen-inno-medical-technology)
- Fujifilm Corporation: 1 (https://510kreport.com/company/fujifilm)
- Chengdu Wision Medical Device Co., Ltd.: 1 (https://510kreport.com/company/chengdu-wision-medical-device)
- Iterative Scopes, Inc.: 1 (https://510kreport.com/company/iterative-scopes)
- Magentiq Eye, Ltd.: 1 (https://510kreport.com/company/magentiq-eye)
- Odin Medical Limited: 1 (https://510kreport.com/company/odin-medical)

## Its most-cited devices
- DEN200055: GI Genius (2021), cited by 5
- K211951: GI Genius (2021), cited by 3
- K233964: GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) (2024), cited by 2
- K241887: 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) (2024), cited by 1
- K231143: GI Genius System 100 and GI Genius System 200 (2023), cited by 1

## Recent decisions
- K261369: GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) (May 29, 2026)
- K241887: 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) (Jul 25, 2024)
- K233964: GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) (Jan 12, 2024)
- K231143: GI Genius System 100 and GI Genius System 200 (May 19, 2023)
- K211951: GI Genius (Jul 23, 2021)
- DEN200055: GI Genius (Apr 9, 2021)

Source page: https://510kreport.com/company/cosmo-artificial-intelligence-ai