510(k) K022899 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0
| Applicant | Philips Medical Systems North America Co., Bothell WA, US |
| Decision | Substantially Equivalent, Nov 22, 2002 |
| Received | Sep 3, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022899
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2011 | Philips Medical Systems North America Co. Phillips Philips Allura Xper Systems with Velara Generator, x-ray system. FCO72200184. Terminated |
IZI | None listed |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Integris XPER FD10 F/C Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet).
Intended use fo Terminated |
IZI | None listed |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Integris Allura Flat Detector 9C Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 PRODUCTS 6501 * (number located on the generator cabine Terminated |
IZI | None listed |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips MONOPLANE X-ray Imaging Systems include the Allura XPER FD10 F/C, Allura XPER FD20, Integris H5000/Allura 9 F/C, Integris CV, and Allura 12-15 Monoplane.
The Monoplane system has one C-arm and it c Terminated |
IZI | None listed |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips Integris XPER FD10 F/C Terminated |
IZI | None listed |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips Integris Allura Flat Detector 9C Terminated |
IZI | None listed |
| Jan 25, 2007 | Philips Medical Systems North America Co. Phillips Allura FD 10 FC, X-Ray System, angiographic - a monoplane, digital Allura FD (flat detector) with a 10' Image Intensifier (II). Terminated |
IZI | None listed |
| Jan 25, 2007 | Philips Medical Systems North America Co. Phillips Allura FD20 x-ray system, angiograph, monoplane, digital Allura FD with a 20' detector FD Terminated |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.