510(k) · Cleared
Recalled · Class I · 2026Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura Xper FD Biplane Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · IZI System, X-Ray, Angiographic
Cleared on May 21, 2013 as substantially equivalent to K041949 (Philips Medical Systems North America Co., 2004) and 2 other predicates after a 55-day review. Its family tree reaches back 6 generations to 1989. 2 of the 12 devices in its family, counting itself, have a Class I recall. It has been recalled 75 times, including 11 Class I recalls.
- Decided
- May 21, 2013
- Review
- 55 days
- Class
- Class II
- Product code
- IZI
- Recalls
- 75 (11 Class I)
- Predicates
- 4
Its longest line of descent runs back 6 generations to K890348 (1989). 11 ancestors in all. No later device cites it as a predicate yet. 2 of the 12 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 5 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 4 generations backK020055 Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 2002 · Recalled
- 3 generations backK022899 Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002 · Recalled
- 2 generations backK031333 Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · Recalled
- 1 generation backK041949 Allura Xper FD10Philips Medical Systems North America Co. · 2004 · Recalled
- This deviceK130842 Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper…Philips Medical Systems Nederland B.V. · 2013
Class I recalls in this family
- K033737 Allura Xper FD20direct predicate · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −5 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −4 | K020055 | Philips Integris Allura 9 with FD Option | Philips Medical Systems | 2002 | 2 |
| −3 | K022899 | Philips Integris Allura Flat Detector Release 1.0 | Philips Medical Systems North America Co. | 2002 | 8 |
| −2 | K031333 | Philips Integris Allura Flat Detector Release 1.2 | Philips Medical Systems North America, Inc. | 2003 | 25 |
| −1 | K041949 | Allura Xper FD10 | Philips Medical Systems North America Co. | 2004 | 48 |
| 0 (this device) | K130842 | Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20… | Philips Medical Systems Nederland B.V. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IZI device
- #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K100205 | FDA’s K100205 is Frontier Devices Neuro System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
| * | K041949 | Allura Xper FD10Summary page 1…*Allura Xper FD OR Table series (1(102005 - cleared by FDA on August 9, 2010); *Allura Xper FDIO series (K041949 - cleared by FDA on July 30, 2004); *Allura Xper FD2O series (K033737 - cleared by FDA on December 9,… | 2004 |
| * | K033737 | Allura Xper FD20Summary page 1…9, 2010); *Allura Xper FDIO series (K041949 - cleared by FDA on July 30, 2004); *Allura Xper FD2O series (K033737 - cleared by FDA on December 9, 2003); *Integris Series Release 2 (K(984545… | 2003 |
| * | K984545 | Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000) SystemsSummary page 1…*Allura Xper FD2O series (K033737 - cleared by FDA on December 9, 2003); *Integris Series Release 2 (K(984545 - cleared by FDA on February 25, 1999). Note: the Integris Series Release 2 systems are currently mar… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 17, 2026 | Class II | Z-2893-2026 | Under Investigation by firm | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. |
| Jun 17, 2026 | Class II | Z-2891-2026 | Under Investigation by firm | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. |
| May 18, 2026 | Class II | Z-2412-2026 | Radiation Control for Health and Safety Act | Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection |
| Apr 30, 2026 | Class II | Z-2259-2026 | Under Investigation by firm | It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the… |
| Apr 30, 2026 | Class II | Z-2258-2026 | Under Investigation by firm | It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the… |
| Dec 15, 2025 | Class II | Z-1064-2026 | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not… |
| Dec 15, 2025 | Class II | Z-1063-2026 | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not… |
| Dec 15, 2025 | Class II | Z-1073-2026 | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not… |
| Dec 15, 2025 | Class II | Z-1074-2026 | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not… |
| Dec 15, 2025 | Class II | Z-1077-2026 | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not… |
| Dec 15, 2025 | Class II | Z-1076-2026 | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not… |
| Dec 15, 2025 | Class II | Z-1068-2026 | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not… |
| Dec 15, 2025 | Class II | Z-1075-2026 | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not… |
| Dec 15, 2025 | Class II | Z-1069-2026 | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not… |
| Dec 15, 2025 | Class II | Z-1062-2026 | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not… |
| Dec 15, 2025 | Class II | Z-1072-2026 | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not… |
| Dec 15, 2025 | Class II | Z-1071-2026 | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not… |
| Dec 15, 2025 | Class II | Z-1065-2026 | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not… |
| Dec 15, 2025 | Class II | Z-1070-2026 | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not… |
| Dec 15, 2025 | Class II | Z-1066-2026 | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not… |
| Dec 15, 2025 | Class II | Z-1067-2026 | Other | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not… |
| Sep 3, 2025 | Class II | Z-2630-2025 | Device Design | Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become… |
| Sep 3, 2025 | Class II | Z-2632-2025 | Device Design | Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become… |
| Sep 3, 2025 | Class II | Z-0008-2026 | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the… |
| Sep 3, 2025 | Class II | Z-2624-2025 | Device Design | Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become… |
| Sep 3, 2025 | Class II | Z-0006-2026 | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the… |
| Sep 3, 2025 | Class II | Z-0001-2026 | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the… |
| Sep 3, 2025 | Class II | Z-0009-2026 | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the… |
| Sep 3, 2025 | Class II | Z-2626-2025 | Device Design | Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become… |
| Sep 3, 2025 | Class II | Z-2623-2025 | Device Design | Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become… |
| Sep 3, 2025 | Class II | Z-0010-2026 | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the… |
| Sep 3, 2025 | Class II | Z-0004-2026 | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the… |
| Sep 3, 2025 | Class II | Z-2634-2025 | Device Design | Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become… |
| Sep 3, 2025 | Class II | Z-2629-2025 | Device Design | Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become… |
| Sep 3, 2025 | Class II | Z-2633-2025 | Device Design | Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become… |
| Sep 3, 2025 | Class II | Z-2635-2025 | Device Design | Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become… |
| Sep 3, 2025 | Class II | Z-0002-2026 | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the… |
| Sep 3, 2025 | Class II | Z-0011-2026 | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the… |
| Sep 3, 2025 | Class II | Z-2628-2025 | Device Design | Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become… |
| Sep 3, 2025 | Class II | Z-2625-2025 | Device Design | Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become… |
| Sep 3, 2025 | Class II | Z-0005-2026 | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the… |
| Sep 3, 2025 | Class II | Z-0012-2026 | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the… |
| Sep 3, 2025 | Class II | Z-0014-2026 | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the… |
| Sep 3, 2025 | Class II | Z-0003-2026 | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the… |
| Sep 3, 2025 | Class II | Z-2631-2025 | Device Design | Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become… |
| Sep 3, 2025 | Class II | Z-2627-2025 | Device Design | Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become… |
| Sep 3, 2025 | Class II | Z-0015-2026 | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the… |
| Sep 3, 2025 | Class II | Z-0007-2026 | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the… |
| Sep 3, 2025 | Class II | Z-0013-2026 | Device Design | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the… |
| Aug 1, 2025 | Class II | Z-2504-2025 | Under Investigation by firm | Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series. |
The 5 latest of 50 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K033737Allura Xper FD20Philips Medical Systems North America, Inc. · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 113 Class I recalls
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 9 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K041949.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · IZI
2in 2025
2007high 7 (2007) · low 0 (2015)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
2007high 111 (2014) · low 28 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
2007high 52 (2008) · low 0 (2022)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
2007high 2,171 (2025) · low 14 (2020)2025
MAUDE reports naming product code IZI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 28 | 6 | 92 |
| 2008 | 6 | 68 | 52 | 101 |
| 2009 | 2 | — | 18 | 132 |
| 2010 | 2 | — | 11 | 252 |
| 2011 | 4 | 104 | 6 | 377 |
| 2012 | 1 | — | 6 | 77 |
| 2013 | 1 | — | 6 | 58 |
| 2014 | 4 | 111 | 5 | 123 |
| 2015 | 0 | — | 14 | 36 |
| 2016 | 1 | — | 7 | 102 |
| 2017 | 2 | — | 1 | 88 |
| 2018 | 2 | — | 2 | 49 |
| 2019 | 2 | — | 2 | 30 |
| 2020 | 1 | — | 2 | 14 |
| 2021 | 1 | — | 1 | 29 |
| 2022 | 1 | — | 0 | 265 |
| 2023 | 3 | 81 | 0 | 1,204 |
| 2024 | 2 | — | 0 | 1,332 |
| 2025 | 2 | — | 0 | 2,171 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Allura Xper FD X-ray imaging systems are indicated for use on human patients to perform: * Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs. stent placements, embolisations and thrombolysis. * Cardiac imaging applications including diagnostics, interventional and…
Read the full statement (130 words)
The Allura Xper FD X-ray imaging systems are indicated for use on human patients to perform:
* Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs. stent placements, embolisations and thrombolysis.
* Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP).
* Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.
Combined with a qualified, compatible Operating Room (OR) table, the Allura Xper FD OR Table X-ray imaging systems can be used for imaging in the hybrid OR within the application domains neuro, vascular, non-vascular and cardiac. The OR table can also be used stand-alone for surgical use in the OR.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130842: Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura Xper FD Biplane Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130842
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026