K232712
- 510(k) number
- K232712
- Device name
- uMI Panorama
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd. CN
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2023-10-03
- Date received
- 2023-09-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K232712.pdf
Official FDA record: K232712
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.