FDA 510(k)
FDA class 2
Substantially Equivalent
🇵🇹 Portugal
PeekMed web (v1)
K Number: K222767
·
Decision Dec 30, 2022
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
7
Review Days
108
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Basic Information
- Device Name
- PeekMed web (v1)
- K Number
- K222767
- 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 13, 2022
- Decision Date
- December 30, 2022
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by Peek Health, S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K252856 | PeekMed web | Dec 22, 2025 | Substantially Equivalent |
| 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 |
| K182464 | PeekMed | Oct 25, 2018 | Substantially Equivalent |