K241585
- 510(k) number
- K241585
- Device name
- uMI Panorama
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd. CN
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2024-08-30
- Date received
- 2024-06-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K241585.pdf
Official FDA record: K241585
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.