K241079
- 510(k) number
- K241079
- Device name
- uCT 780
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd. CN
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2025-01-07
- Date received
- 2024-04-19
- 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: K241079.pdf
Official FDA record: K241079
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.