K261427
- 510(k) number
- K261427
- Device name
- uMI Panvivo (uMI Panvivo M)
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd. CN
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2026-07-28
- Date received
- 2026-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K261427.pdf
Official FDA record: K261427
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.