K233176
- 510(k) number
- K233176
- Device name
- uOmnispace.MI
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd. CN
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2023-12-20
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K233176.pdf
Official FDA record: K233176
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.