SKOUT Software
FDA 510(k) clearance K213686 · decided 2022-08-12
Clearance details
- K-number
- K213686
- Device name
- SKOUT Software
- Applicant
- Iterative Scopes, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-11-22
- Decision date
- 2022-08-12
- Days to decision
- 263 days
- Clearance type
- Traditional
- Product code
- QNP
- Device class
- 2
- Regulation number
- 876.1520
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EW10-EC02 Endoscopy Support Program (K260567) | Fujifilm Corporation | 2026-08-07 |
| CAD - Lower GI (EC07-01) (K252853) | Xiamen Inno Medical Technology Co., Ltd. | 2026-08-05 |
| GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) (K261369) | Cosmo Artificial Intelligence - Ai, Ltd. | 2026-05-29 |
| MAGENTIQ-COLO (ME-APDS) (K260724) | Magentiq Eye, Ltd. | 2026-04-03 |
| SKOUT system (K253664) | Iterative Health | 2025-12-22 |
| MAGENTIQ-COLO (ME-APDS) (K252178) | Magentiq Eye, Ltd. | 2025-10-03 |
| CADDIE (K252586) | Odin Medical Limited | 2025-09-12 |
| SKOUT system (K251126) | Iterative Health | 2025-05-09 |
| MAGENTIQ-COLO (ME-APDS) (K244023) | Magentiq Eye, Ltd. | 2025-01-24 |
| 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) (K241887) | Cosmo Artificial Intelligence - Ai, Ltd. | 2024-07-25 |
| CADDIE (K240044) | Odin Medical Limited | 2024-07-24 |
| SKOUT® system (K241508) | Iterative Scopes, Inc. | 2024-07-03 |
Recalls involving this device
No recalls on record reference this clearance.