K250738
- 510(k) number
- K250738
- Device name
- YSIO X.pree
- Applicant
- Siemens Medical Solutions PA · US
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2025-07-31
- Date received
- 2025-03-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250738.pdf
Official FDA record: K250738
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.