510(k) K973482 ยท IZI System, X-Ray, Angiographic
PHILIPS INTEGRIS V5000 AND BV5000
| Applicant | Philips Medical Systems North America, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Nov 10, 1997 |
| Received | Sep 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973482
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS H5000; Model Number: 72246
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane Terminated |
IZI | None listed |
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS BH5000; Model Number: 72247
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane Terminated |
IZI | None listed |
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS V5000: Model Number: 72248
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane Terminated |
IZI | None listed |
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS BV5000: Model Number: 72249
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane Terminated |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.