K252000
- 510(k) number
- K252000
- Device name
- uDR Arria & uDR Aris
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd. CN
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2025-11-26
- Date received
- 2025-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K252000.pdf
Official FDA record: K252000
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.