FDA 510(k)
FDA class 2
Substantially Equivalent
🇵🇹 Portugal
PeekMed web
K Number: K252856
·
Decision Dec 22, 2025
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
7
Review Days
104
Basic Information
- Device Name
- PeekMed web
- K Number
- K252856
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Peek Health, S.A.
- Date Received
- September 9, 2025
- Decision Date
- December 22, 2025
- Product Code
- QIH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | FDA class 2 | Radiology |
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Other Clearances by Peek Health, S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K252452 | PeekMed web | Nov 12, 2025 | Substantially Equivalent |
| K251096 | PeekMed web | Jul 14, 2025 | Substantially Equivalent |
| K250042 | PeekMed web | Mar 19, 2025 | Substantially Equivalent |
| K240926 | PeekMed web | Dec 6, 2024 | Substantially Equivalent |
| K222767 | PeekMed web (v1) | Dec 30, 2022 | Substantially Equivalent |
| K182464 | PeekMed | Oct 25, 2018 | Substantially Equivalent |