K251167
- 510(k) number
- K251167
- Device name
- uDR Aurora CX
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd. CN
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2025-09-19
- Date received
- 2025-04-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.4 MB · U.S. public domain
Also available from FDA: K251167.pdf
Official FDA record: K251167
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.