510(k) K181413 ยท KPR System, X-Ray, Stationary
uDR 592h, uDR 596i
| Applicant | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Jun 27, 2018 |
| Received | May 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181413
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2021 | Shanghai United Imaging Healthcare Co., Ltd. Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric s Terminated |
KPR | None listed |
| Feb 27, 2020 | Shanghai United Imaging Healthcare Co., Ltd. uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exp Terminated |
KPR | None listed |
| Jul 30, 2019 | Shanghai United Imaging Healthcare Co., Ltd. Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.