FDA 510(k) Applications for Medical Device Product Code "QNP"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K211326 | Chengdu Wision Medical Device Co., LTD. | EndoScreener | 11/19/2021 |
| K211951 | Cosmo Artificial Intelligence - AI Ltd | GI Genius | 07/23/2021 |
| K231143 | Cosmo Artificial Intelligence - AI Ltd | GI Genius System 100 and GI Genius System 200 | 05/19/2023 |
| K233964 | Cosmo Artificial Intelligence - AI Ltd | GI GeniusÖ Module 100 (GGM100.US); GI GeniusÖ Module 200 (GGM200.US); ColonPROÖ 4.0 (CPRO40.US) | 01/12/2024 |
| K241887 | Cosmo Artificial Intelligence - AI Ltd | GI GeniusÖ Module 100 (GGM100.US); GI GeniusÖ Module 200 (GGM200.US); ColonPROÖ 4.0 (CPRO40.US); GI GeniusÖ Module 300 (GGM300-US); ColonPROÖ 4.0 (CPRO40S-US) | 07/25/2024 |
| DEN200055 | Cosmo Artificial Intelligence - AI, LTD | GI Genius | 04/09/2021 |
| K230751 | FUJIFILM Corporation | EW10-EC02 Endoscopy Support Program | 12/15/2023 |
| K251126 | Iterative Health | SKOUT system | 05/09/2025 |
| K213686 | Iterative Scopes Inc. | SKOUT Software | 08/12/2022 |
| K230658 | Iterative Scopes Inc. | SKOUT« system | 04/07/2023 |
| K241508 | Iterative Scopes, Inc. | SKOUT« system | 07/03/2024 |
| K240781 | Iterative Scopes, Inc. | SKOUT« system | 04/19/2024 |
| K244023 | Magentiq Eye LTD | MAGENTIQ-COLO (ME-APDS) | 01/24/2025 |
| K223473 | Magentiq Eye LTD | ME-APDSÖ; MAGENTIQ-COLOÖ | 07/25/2023 |
| K240044 | Odin Medical Limited | CADDIE | 07/24/2024 |
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