FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SKOUT system
K Number: K251126
·
Decision May 9, 2025
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
19
Applicant Total
2
Review Days
28
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SKOUT system
- K Number
- K251126
- 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
- April 11, 2025
- Decision Date
- May 9, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QNP), ordered by most recent decision date.
GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MAGENTIQ-COLO (ME-APDS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SKOUT system
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MAGENTIQ-COLO (ME-APDS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CADDIE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MAGENTIQ-COLO (ME-APDS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Iterative Health
| K Number | Device Name | ||
|---|---|---|---|
| K253664 | SKOUT system | Dec 22, 2025 | Substantially Equivalent |