510(k) K984545 ยท IZI System, X-Ray, Angiographic
RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS
| Applicant | Philips Medical Systems North America, Inc., Da Best, NL |
| Decision | Substantially Equivalent, Feb 25, 1999 |
| Received | Dec 22, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984545
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 19, 2019 | Philips Medical Systems Nederlands Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038
Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, Terminated |
IZI | None listed |
| Feb 19, 2019 | Philips Medical Systems Nederlands Foot Switches used with the following systems:
722001 Allura Xper FD 10 C
722002 Allura Xper FD10 F
722003 Allura Xper FD10
722005 Allura Xper FD10/10
722006 Allura Xper FD20
722008 Allura Xper FD2 Terminated |
IZI | None listed |
| Sep 24, 2014 | Philips Medical Systems, Inc. Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper Terminated |
IZI | None listed |
| Mar 16, 2011 | Philips Medical Systems North America Co. Phillips Philips Allura Integris Systems with OMCP Generator, x-ray diagnostic system. FCO72200185. Terminated |
IZI | None listed |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Allura XPER 10/10 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 for Ang Terminated |
IZI | None listed |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Integris H5000F 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 for Angio Terminated |
IZI | None listed |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Integris BH5000 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 for Angio Terminated |
IZI | None listed |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Allura XPER FD 20/10 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 for 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 22, 2010 | Philips Medical Systems North America Co. Phillips BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10, FD20/20, Integris BH5000, and Integris Allura 12-15 Biplane.
The BIPLANE system has two C-arms and it allows the operator to im Terminated |
IZI | None listed |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips Allura XPER 10/10 Terminated |
IZI | None listed |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips Integris H5000F Terminated |
IZI | None listed |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips Integris BH5000 Terminated |
IZI | None listed |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips Allura XPER FD20/10 Terminated |
IZI | None listed |
| Jan 25, 2007 | Philips Medical Systems North America Co. Phillips Allura Mono X-Ray System, angiographic - monoplane, analog Allura with a 12' and 15' Image Intensifier Terminated |
IZI | None listed |
| Nov 29, 2005 | Philips Medical Systems North America Co. Phillips AD5 table for use with Integris and Integris Allura x-ray systems Terminated |
IZI | None listed |
| Nov 29, 2005 | Philips Medical Systems North America Co. Phillips AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt version. Terminated |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.