510(k) K170144 ยท OWB Interventional Fluoroscopic X-Ray System
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| Applicant | Philips Medical Stystems Nederland BV, Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Jun 7, 2017 |
| Received | Jan 17, 2017 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K170144
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2022 | Philips North America Llc Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.