Caddie
FDA 510(k) K252586 · Odin Medical Limited
510(k) numberK252586
Submission
- Device name
- Caddie
- Applicant
- Odin Medical Limited
London, GB - Received
- August 15, 2025
- Decision date
- September 12, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QNP – Gastrointesinal Lesion Software Detection System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1520
- Specialty
- Gastroenterology, Urology
A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope.
Other 510(k)s with product code QNP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260133 | CaddieQNP · Special | Odin Medical Limited | 09/12/2026SE |
| K260567 | EW10-EC02 Endoscopy Support ProgramQNP · Special | Fujifilm Corporation | 08/07/2026SE |
| K252853 | CAD - Lower GI (EC07-01)QNP · Traditional | Xiamen Inno Medical Technology Co., Ltd. | 08/05/2026SE |
| K261369 | GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)QNP · Special | Cosmo Artificial Intelligence - Ai, Ltd. | 05/29/2026SE |
| K260724 | Magentiq-Colo (Me-Apds)QNP · Special | Magentiq Eye, Ltd. | 04/03/2026SE |
| K253664 | SKOUT systemQNP · Special | Iterative Health | 12/22/2025SE |
| K252178 | Magentiq-Colo (Me-Apds)QNP · Special | Magentiq Eye, Ltd. | 10/03/2025SE |
| K251126 | SKOUT systemQNP · Special | Iterative Health | 05/09/2025SE |
| K244023 | Magentiq-Colo (Me-Apds)QNP · Special | Magentiq Eye, Ltd. | 01/24/2025SE |
| K241887 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0…QNP · Special | Cosmo Artificial Intelligence - Ai, Ltd. | 07/25/2024SE |
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Questions and answers
When was Caddie cleared by the FDA?
Caddie (K252586) received a 510(k) decision of Substantially Equivalent on September 12, 2025, 28 days after the submission was received.
What is the product code of K252586?
The FDA product code is QNP – Gastrointesinal Lesion Software Detection System, a Class II (moderate risk) device regulated under 21 CFR 876.1520.