K253564
- 510(k) number
- K253564
- Device name
- uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd. CN
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2026-02-13
- Date received
- 2025-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253564.pdf
Official FDA record: K253564
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.