K251710
- 510(k) number
- K251710
- Device name
- Mobile X-ray unit (!M1)
- Applicant
- Solutions For Tomorrow AB SE
- Product code
- IZL — System, X-Ray, Mobile
- Decision date
- 2025-10-24
- Date received
- 2025-06-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K251710.pdf
Official FDA record: K251710
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.