510(k) K141381 ยท KPR System, X-Ray, Stationary
DURADIAGNOST
| Applicant | Philips Healthcare (Suzhou) Co., Ltd., Suzhou Jiangsu, CN |
| Decision | Substantially Equivalent, Jun 12, 2014 |
| Received | May 27, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141381
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2025 | Philips North America Llc Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System. Open, Classified |
KPR | None listed |
| Apr 11, 2025 | Philips North America Llc Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System. Open, Classified |
KPR | None listed |
| May 31, 2017 | Philips Electronics North America Corporation Philips DuraDiagnost X-ray systems:
DuraDiagnost (R1.0, Product Number 712210)
DuraDiagnost (R2.0, Product Number 712211)
DuraDiagnost (R3.0, Product Number 712211) Terminated |
KPR | None listed |
| Sep 1, 2016 | Philips Electronics North America Corporation Philips DuraDiagnost stationary X-ray system Terminated |
KPR | None listed |
| Jun 3, 2016 | Philips Healthcare Philips Healthcare DuraDiagnost stationary X-ray system Terminated |
KPR | None listed |
| May 19, 2015 | Philips Medical Systems, Inc. Philips Healthcare DuraDiagnost X- Ray Terminated |
KPR | None listed |
| Mar 6, 2015 | Philips Medical Systems, Inc. Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic
Models: 712210, 712211 Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.