FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
SKIA-Head (Model: SKIA-ST00)
K Number: K253486
·
Decision Feb 23, 2026
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
1
Review Days
129
Basic Information
- Device Name
- SKIA-Head (Model: SKIA-ST00)
- K Number
- K253486
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Skia, Inc.
- Date Received
- October 17, 2025
- Decision Date
- February 23, 2026
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
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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