510(k) K182938 ยท KPS System, Tomography, Computed, Emission
Emission Computed Tomography System
| Applicant | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Dec 18, 2018 |
| Received | Oct 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182938
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2020 | Shanghai United Imaging Healthcare Co., Ltd. uEXPLORER 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, r Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.