510(k) K211326
- Device
- EndoScreener
- Applicant
- Chengdu Wision Medical Device Co., LTD.
- 510(k) number
- K211326
- Product code
- QNP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-11-19
- Date received
- 2021-04-30
- Regulation
- 876.1520
- Classification name
- Gastrointesinal Lesion Software Detection System
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JingJia Liu
- Address
- Unit 802, Floor 8, Bldg. 17, Yintaicheng, # 1999 Yizhou Rd., Wuhou District Chengdu CN 610041 610041
FDA Registration Numbers#
- 3002808148
- 3018899987
- 3016591389
- 3031983124
- 8010047
- 3011050570
- 3030626336
- 3018901422
- 3016432796
- 3003775006
- 9610877
- 3042225166
Source Documents#
Other 510(k) Records For Product Code QNP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260724 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | 2026-04-03 |
| K253664 | SKOUT system | Iterative Health | 2025-12-22 |
| K252178 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | 2025-10-03 |
| K252586 | CADDIE | Odin Medical Limited | 2025-09-12 |
| K251126 | SKOUT system | Iterative Health | 2025-05-09 |
| K244023 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | 2025-01-24 |
| 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) | Cosmo Artificial Intelligence - Ai, Ltd. | 2024-07-25 |
| K240044 | CADDIE | Odin Medical Limited | 2024-07-24 |
| K241508 | SKOUT® system | Iterative Scopes, Inc. | 2024-07-03 |
| K240781 | SKOUT® system | Iterative Scopes, Inc. | 2024-04-19 |
| K233964 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) | Cosmo Artificial Intelligence - Ai, Ltd. | 2024-01-12 |
| K230751 | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | 2023-12-15 |
| K223473 | ME-APDS™; MAGENTIQ-COLO™ | Magentiq Eye, Ltd. | 2023-07-25 |
| K231143 | GI Genius System 100 and GI Genius System 200 | Cosmo Artificial Intelligence - Ai, Ltd. | 2023-05-19 |
| K230658 | SKOUT® system | Iterative Scopes, Inc. | 2023-04-07 |
Legacy Summary#
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FDA Review#
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