510(k) K243617 ยท JAK System, X-Ray, Tomography, Computed
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis
| Applicant | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, May 16, 2025 |
| Received | Nov 22, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243617
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT ATLAS with software Open, Classified |
JAK | None listed |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT ATLAS Astound with software Open, Classified |
JAK | None listed |
| Oct 21, 2025 | UIH Technologies LLC Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System,
Model:uCT ATLAS
MD, Rx Only Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.