K250788
- 510(k) number
- K250788
- Device name
- Definium Tempo Select
- Applicant
- Ge Hualun Medical Systems Co. , Ltd. CN
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2025-08-28
- Date received
- 2025-03-14
- 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: K250788.pdf
Official FDA record: K250788
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.