510(k) K031333 ยท IZI System, X-Ray, Angiographic
PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2
| Applicant | Philips Medical Systems North America, Inc., Da Best, NL |
| Decision | Substantially Equivalent, May 13, 2003 |
| Received | Apr 28, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031333
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD10
Catalog
(1) 722003
(2) 722010
(3)722026 Open, Classified |
OWB | None listed |
| Feb 16, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems.
Affected PCs: Imaging Processing PC, Host PC, FlexVision PC
Allura X Open, Classified |
OWB | None listed |
| 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 21, 2018 | Philips Electronics North America Corporation INTEGRIS Allura 9, System Code 722018
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | None listed |
| Sep 21, 2018 | Philips Electronics North America Corporation INTEGRIS Allura 9 (biplane), System Code 722021
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | None listed |
| Sep 21, 2018 | Philips Electronics North America Corporation INTEGRIS CV, System Code 722030
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | None listed |
| Sep 21, 2018 | Philips Electronics North America Corporation INTEGRIS Allura 15-12 (mono), System Code 722043
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | None listed |
| Sep 21, 2018 | Philips Electronics North America Corporation INTEGRIS Allura 15-12 (biplane), System Code 722044
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | None listed |
| Sep 21, 2018 | Philips Electronics North America Corporation INTEGRIS SUITE, System Code 722199
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | None listed |
| Sep 21, 2018 | Philips Electronics North America Corporation INTEGRIS Allura 9 F FDXD, System Code 722497
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | None listed |
| Sep 21, 2018 | Philips Electronics North America Corporation NTEGRIS Allura 9 0 FDXD, System Code 722498
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | None listed |
| Mar 22, 2017 | Philips Electronics North America Corporation Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10 722026; Allura Xper FD10/10 722027; Allura Xper FD20/10 biplane 722029; Allura Xper FD10 OR Table 722033; Allura Xper FD10 Terminated |
OWB | None listed |
| Mar 22, 2017 | Philips Electronics North America Corporation The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper FD10 (C+F). 722003; Allura Xper FD10/10 722005; Allura Xper FD20 Terminated |
OWB | 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 |
| Apr 25, 2012 | Philips Healthcare Inc. Allura X-ray System.
The Allura X-ray System is an angiographic X-ray system. Terminated |
IZI | None listed |
| Aug 10, 2011 | Philips Healthcare Inc. Allura Xper Systems Models:
Allura Xper FD10 (F/C)-Biplane Fixed
Allura Xper FD10/10 (incl. OR table)
Allura Xper FD20- High resolution fixed-x ray
Allura Xper FD20/10
Allura Xper FD20/20
Allura CV20 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 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 |
| Jan 25, 2007 | Philips Medical Systems North America Co. Phillips FD 10/10 X-Ray System, Angiograph, bi-plane digital Allura FD, 10' detector Terminated |
IZI | None listed |
| Nov 14, 2006 | Philips Medical Systems North America Co. Phillips Allura X-per FD 10/10 x-ray, and fluoroscopy Terminated |
IZI | None listed |
| Feb 28, 2006 | Philips Medical Systems North America Co. Phillips Allura Xper FD10/10 x-ray system 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.