FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SKOUT system
K Number: K253664
·
Decision Dec 22, 2025
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
19
Applicant Total
2
Review Days
32
Basic Information
- Device Name
- SKOUT system
- K Number
- K253664
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1520
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Iterative Health
- Date Received
- November 20, 2025
- Decision Date
- December 22, 2025
- Product Code
- QNP
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QNP | Gastrointesinal Lesion Software Detection System | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Iterative Health
| K Number | Device Name | ||
|---|---|---|---|
| K251126 | SKOUT system | May 9, 2025 | Substantially Equivalent |