K233209
- 510(k) number
- K233209
- Device name
- uOmnispace.CT
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd. CN
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-05-17
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K233209.pdf
Official FDA record: K233209
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.