K250045
- 510(k) number
- K250045
- Device name
- uWS-Angio Pro
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd. CN
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-09-24
- Date received
- 2025-01-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K250045.pdf
Official FDA record: K250045
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.