510(k) K200016 ยท JAK System, X-Ray, Tomography, Computed
uCT 530, uCT 550
| Applicant | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Feb 25, 2020 |
| Received | Jan 3, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200016
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT 530 with software Open, Classified |
JAK | None listed |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT 550 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 530
MD, Rx Only Open, Classified |
JAK | None listed |
| Oct 21, 2025 | UIH Technologies LLC Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System,
Model:uCT 550
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.