K253486
- 510(k) number
- K253486
- Device name
- SKIA-Head (Model: SKIA-ST00)
- Applicant
- Skia, Inc. KR
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2026-02-23
- Date received
- 2025-10-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K253486.pdf
Official FDA record: K253486
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.