510(k) K181414 ยท JAK System, X-Ray, Tomography, Computed
uCT 530, uCT 550
| Applicant | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Aug 14, 2018 |
| Received | May 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181414
| 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 |
| Aug 5, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission d Open, Classified |
JAK | None listed |
| Aug 5, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - 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 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray tran Open, Classified |
JAK | None listed |
| Jul 27, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray tran Open, Classified |
JAK | None listed |
| Jul 20, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036
Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce Open, Classified |
JAK | None listed |
| May 8, 2020 | Shanghai United Imaging Healthcare Co., Ltd. uCT 530 Computed Tomography X-Ray System Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.