510(k) K182237 ยท KPS System, Tomography, Computed, Emission
uMI 550 PET/CT System
| Applicant | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Oct 12, 2018 |
| Received | Aug 17, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182237
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software Open, Classified |
KPS | None listed |
| Oct 21, 2025 | UIH Technologies LLC Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System
Model:uMI 550
MD, Rx Only Open, Classified |
JAK | None listed |
| Apr 7, 2023 | Shanghai United Imaging Healthcare Co., Ltd. Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550
Part Number:
88000657
88000057 Open, Classified |
KPS | None listed |
| Oct 13, 2022 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI 550 Open, Classified |
KPS | None listed |
| Aug 2, 2021 | Shanghai United Imaging Healthcare Co., Ltd. uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment Open, Classified |
KPS | None listed |
| Aug 2, 2021 | Shanghai United Imaging Healthcare Co., Ltd. uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and t Open, Classified |
KPS | None listed |
| Aug 13, 2020 | Shanghai United Imaging Healthcare Co., Ltd. uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, res Terminated |
JAK | None listed |
| Aug 5, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in th Open, Classified |
KPS | None listed |
| Mar 26, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to Terminated |
KPS | None listed |
| Aug 26, 2019 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is intended Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.