K231762
- 510(k) number
- K231762
- Device name
- uEXPLORER
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd. CN
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2024-01-18
- Date received
- 2023-06-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K231762.pdf
Official FDA record: K231762
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.