K250040
- 510(k) number
- K250040
- Device name
- uWS-Angio
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd. CN
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-09-12
- Date received
- 2025-01-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K250040.pdf
Official FDA record: K250040
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.