K242515
- 510(k) number
- K242515
- Device name
- uDR 380i Pro
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd. CN
- Product code
- IZL — System, X-Ray, Mobile
- Decision date
- 2024-10-10
- Date received
- 2024-08-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K242515.pdf
Official FDA record: K242515
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.