510(k) K162148 ยท OWB Interventional Fluoroscopic X-Ray System
Allura Xper R9
| Applicant | Philips Medical Systems Nethrlands BV, Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Nov 23, 2016 |
| Received | Aug 1, 2016 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K162148
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2021 | Philips North America Llc The Azurion series (within the limits of the used Operation Room table) are intended for use to perform:
"Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the Terminated |
OWB | None listed |
| Feb 10, 2020 | Philips North America, LLC VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion Terminated |
OWB | None listed |
| Dec 18, 2017 | Philips Electronics North America Corporation Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20
The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neuro Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.