510(k) K172135 ยท JAK System, X-Ray, Tomography, Computed
uCT Computed Tomography X-ray System
| Applicant | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Mar 2, 2018 |
| Received | Jul 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172135
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT 760 with software Open, Classified |
JAK | None listed |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT 780 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 760
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 780
MD, Rx Only Open, Classified |
JAK | None listed |
| Aug 5, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission d Open, Classified |
JAK | None listed |
| Jul 27, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray tran Open, Classified |
JAK | None listed |
| May 8, 2020 | Shanghai United Imaging Healthcare Co., Ltd. uCT 760 System, Computed Tomography X-ray System Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.