K234154
- 510(k) number
- K234154
- Device name
- uPMR 790
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd. CN
- Product code
- OUO — Tomographic Imager Combining Emission Computed Tomog
- Decision date
- 2024-05-24
- Date received
- 2023-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K234154.pdf
Official FDA record: K234154
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.