510(k) K163410 ยท KPR System, X-Ray, Stationary
DigitalDiagnost C50
| Applicant | Philips Healthcare (Suzhou) Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Jan 4, 2017 |
| Received | Dec 5, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163410
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2023 | Philips North America Llc Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy
Model Number : 712201 Open, Classified |
KPR | None listed |
| Apr 12, 2023 | Philips North America Llc DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy
Model Number : 712204 Open, Classified |
KPR | None listed |
| Sep 1, 2022 | Philips North America Llc DigitalDiagnost C50 1.1 Open, Classified |
KPR | None listed |
| Dec 21, 2018 | Philips Healthcare DigitalDiagnost C50, Stationary X-ray System Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.