K231482
- 510(k) number
- K231482
- Device name
- uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd. CN
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2023-11-29
- Date received
- 2023-05-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K231482.pdf
Official FDA record: K231482
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.