510(k) · Cleared
Recalled · Class II · 2025Allura Xper FD10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America Co. · IZI System, X-Ray, Angiographic
Cleared on Jul 30, 2004 as substantially equivalent to K031333 (Philips Medical Systems North America, Inc., 2003) after a 10-day review. Its family tree reaches back 5 generations to 1989. 10 of the 73 devices in its family, counting itself, have a Class I recall. 64 later devices descend from it. It has been recalled 48 times.
- Decided
- Jul 30, 2004
- Review
- 10 days
- Class
- Class II
- Product code
- IZI
- Recalls
- 48
- Predicates
- 1
Its longest line of descent runs back 5 generations to K890348 (1989). 8 ancestors in all. 64 later devices descend from it, 5 citing it directly. 10 of the 73 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 4 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 3 generations backK020055 Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 2002 · Recalled
- 2 generations backK022899 Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002 · Recalled
- 1 generation backK031333 Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · Recalled
- This deviceK041949 Allura Xper FD10Philips Medical Systems North America Co. · 2004
- Descendant · cites it directly · 36 of its ownK082907 IC-Pro System, Version 3.1.0.4Paieon, Inc. · 2008
- Descendant · 2 generations on · 30 of its ownK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- Descendant · cites it directly · 24 of its ownK102005 Allura Xper or Table SeriesPhilips Medical Systems North America, Inc. · 2010 · Recalled
- Descendant · cites it directly · 18 of its ownK130638 Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V. · 2013 · Recalled
- Descendant · 2 generations on · 15 of its ownK133292 Allura Xper FD; or TablePhilips Medical Systems Nederland B.V. · 2014 · Recalled
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
2008high 7 (2014) · low 1 (2008)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 64 · See all- K082907IC-Pro System, Version 3.1.0.4Paieon, Inc. · 2008 · cites it directly36descendants
- K083745The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009 · 2 generations on30descendants
- K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc. · 2010 · cites it directly24descendants
- K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V. · 2013 · cites it directly18descendants
- K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V. · 2014 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −4 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −3 | K020055 | Philips Integris Allura 9 with FD Option | Philips Medical Systems | 2002 | 2 |
| −2 | K022899 | Philips Integris Allura Flat Detector Release 1.0 | Philips Medical Systems North America Co. | 2002 | 8 |
| −1 | K031333 | Philips Integris Allura Flat Detector Release 1.2 | Philips Medical Systems North America, Inc. | 2003 | 25 |
| 0 (this device) | K041949 | Allura Xper FD10 | Philips Medical Systems North America Co. | 2004 | — |
| +1 | K082907 | IC-Pro System, Version 3.1.0.4 | Paieon, Inc. | 2008 | — |
| +2 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| +1 | K102005 | Allura Xper or Table Series | Philips Medical Systems North America, Inc. | 2010 | 39 |
| +1 | K130638 | Alluraclarity Xper FD Series X-Ray System | Philips Medical Systems Nederland B.V. | 2013 | 39 |
| +2 | K133292 | Allura Xper FD; or Table | Philips Medical Systems Nederland B.V. | 2014 | 45 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 1 |
| 2014 | 7 | 0 |
| 2015 | 2 | 0 |
| 2016 | 7 | 1 |
| 2017 | 3 | 2 |
| 2018 | 3 | 0 |
| 2019 | 2 | 1 |
| 2020 | 1 | 1 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 1 |
| 2024 | 3 | 2 |
| 2025 | 7 | 1 |
| 2026 | 4 | 0 |
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.
10 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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031333 | Philips Integris Allura Flat Detector Release 1.2Summary page 1…manufactured by Philips Medical Systems Nederland B.V. The Philips Integris Allura Flat Detector release 1.2 received a 510(k) substantially equivalent determination in K031333 on May 13 th, 2003. Device description: The Allura Xper FD10 is a stationary angiographic X-ray imaging system with a solid stat… | 2003 |
What descends from it? (64)
See all 645 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082907 | IC-Pro System, Version 3.1.0.4 | 2008 | 36 |
| K102005 | Allura Xper or Table Series | 2010 | 24 |
| K130638 | Alluraclarity Xper FD Series X-Ray System | 2013 | 18 |
| K130842 | Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura… Class I | 2013 | 0 |
| K092713 | Spectre Wireless Encrypted Footswitch and Hand Switch System | 2010 | 0 |
Has anything in its family been recalled? (10 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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… |
| Jan 13, 2025 | Class II | Z-1077-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Feb 19, 2019 | Class II | Z-1140-2019 | Component design/selection | Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or… |
| Feb 19, 2019 | Class II | Z-1141-2019 | Component design/selection | Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or… |
| Jul 16, 2018 | Class II | Z-3228-2018 | Device Design | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the… |
| Jul 16, 2018 | Class II | Z-3225-2018 | Device Design | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the… |
| Jul 16, 2018 | Class II | Z-3229-2018 | Device Design | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the… |
| Jul 16, 2018 | Class II | Z-3227-2018 | Device Design | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the… |
| Jul 16, 2018 | Class II | Z-3230-2018 | Device Design | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the… |
| Jul 16, 2018 | Class II | Z-3226-2018 | Device Design | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the… |
| Mar 22, 2017 | Class II | Z-1822-2017 | Under Investigation by firm | Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to… |
| Dec 9, 2016 | Class II | Z-1061-2017 | Device Design | System may lock up. |
| Dec 9, 2016 | Class II | Z-1062-2017 | Device Design | System may lock up. |
| Dec 1, 2016 | Class II | Z-0923-2017 | Process control | Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled. |
| Jul 6, 2015 | Class II | Z-0810-2016 | Process control | The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position. |
| Feb 3, 2015 | Class II | Z-0347-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0349-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0354-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0353-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0348-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0350-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0351-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0352-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0346-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Sep 24, 2014 | Class II | Z-1280-2016 | Device Design | Loss of key image functionality due to a bent pedal of the Footswitch. |
| Jul 8, 2011 | Not classified | Z-2976-2011 | Software design | System freezes from 20 seconds up to one minute. No fluoroscopy exposure and no geometry movements during this time period. |
| Nov 4, 2010 | Not classified | Z-1368-2011 | Pending | Adjustment of the micro-switches in the footswitch used on the Philips cardiovascular X-ray systems was not implemented. If it is programmed for exposure, it is possible that after pressing the pedal on the footswitch it does not release… |
| Aug 21, 2008 | Not classified | Z-0124-2011 | Software design | Due to a potential geometry software lock up during a Digital Rotational Angiography (DRA) run, the stand and table movement may no longer be possible. |
| Aug 21, 2008 | Not classified | Z-0125-2011 | Software design | Potential for table and stand not to move due to a software error. |
| Mar 14, 2008 | Not classified | Z-1642-2008 | Device Design | Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation. |
| Aug 24, 2006 | Not classified | Z-0161-2007 | Other | Potential for x-ray system to freeze during an examination, and inability of table to be re-positioned. |
| Aug 24, 2006 | Not classified | Z-0162-2007 | Other | Potential for x-ray system to freeze during an examination, and inability of table to be re-positioned. |
| Oct 12, 2005 | Not classified | Z-0209-06 | Other | Potential for high voltage exposure involving the injector interface connector of patient support tables. |
| Oct 12, 2005 | Not classified | Z-0208-06 | Other | Potential for high voltage exposure involving the injector interface connector of patient support tables. |
The 5 latest of 48 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.
- K130842Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura Xper FD Biplane…Philips Medical Systems Nederland B.V. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 111 Class I recalls
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 6 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 6 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls
Nearest 5 of 10; all are on the web page.
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 8 ancestors have a recall of any class.
- Of its descendants, K082907 (Paieon, Inc., 2008) has gone furthest, with 36 descendants of its own.
- 1 other device also cites its predicate K031333.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 FD10 is intended for cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041949 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041949: Allura Xper FD10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041949
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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