510(k) K173433 ยท OWB Interventional Fluoroscopic X-Ray System
ProxiDiagnost N90
| Applicant | Philips Medical Systems Dmc GmbH, Hamburg, DE |
| Decision | Substantially Equivalent, Feb 5, 2018 |
| Received | Nov 2, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173433
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2023 | Philips North America ProxiDiagnost N90 R.1.0 Open, Classified |
JAA | None listed |
| Apr 28, 2023 | Philips North America Llc Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system Open, Classified |
OWB | None listed |
| Apr 10, 2023 | Philips North America Llc ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110 Open, Classified |
JAA | None listed |
| Sep 22, 2021 | Philips Healthcare ProxiDiagnost N90 is multi-functional general R/F systems. Open, Classified |
OWB | None listed |
| Jan 28, 2021 | PHILIPS HOME HEALTHCARE SOLUTION ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system Terminated |
OWB | None listed |
| Apr 23, 2020 | Philips North America, LLC ProxiDiagnost N90, UDI 706100 Terminated |
JAA | None listed |
| Nov 20, 2019 | Philips North America, LLC ProxiDiagnost N90 Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.