FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
ME-APDS; MAGENTIQ-COLO
K Number: K223473
·
Decision Jul 25, 2023
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
19
Applicant Total
4
Review Days
250
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Basic Information
- Device Name
- ME-APDS; MAGENTIQ-COLO
- K Number
- K223473
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1520
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Magentiq Eye, Ltd.
- Date Received
- November 17, 2022
- Decision Date
- July 25, 2023
- 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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