FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
MAGENTIQ-COLO (ME-APDS)
K Number: K252178
·
Decision Oct 3, 2025
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
19
Applicant Total
4
Review Days
84
Basic Information
- Device Name
- MAGENTIQ-COLO (ME-APDS)
- K Number
- K252178
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1520
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Magentiq Eye, Ltd.
- Date Received
- July 11, 2025
- Decision Date
- October 3, 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
CADDIE
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