Cosmo Artificial Intelligence - AI Ltd

6 AI-enabled medical devices from Cosmo Artificial Intelligence - AI Ltd on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

DecisionNumberDeviceCompanyPanel
2026-05-29K261369GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)Cosmo Artificial Intelligence - Ai, Ltd.Gastroenterology-Urology
2024-07-25K241887GI 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)Cosmo Artificial Intelligence - AI LtdGastroenterology-Urology
2024-01-12K233964GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)Cosmo Artificial Intelligence - AI LtdGastroenterology-Urology
2023-05-19K231143GI Genius System 100 and GI Genius System 200Cosmo Artificial Intelligence - AI LtdGastroenterology-Urology
2021-07-23K211951GI GeniusCosmo Artificial Intelligence - AI LtdGastroenterology-Urology
2021-04-09DEN200055GI GeniusCosmo Artificial Intelligence - AI, LTDGastroenterology-Urology

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