510(k) · Cleared
Recalled · Class II · 2025Philips Integris Allura Flat Detector Release 1.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America, Inc. · IZI System, X-Ray, Angiographic
Cleared on May 13, 2003 as substantially equivalent to K022899 (Philips Medical Systems North America Co., 2002) after a 15-day review. Its family tree reaches back 4 generations to 1989. 10 of the 121 devices in its family, counting itself, have a Class I recall. 113 later devices descend from it. It has been recalled 25 times.
- Decided
- May 13, 2003
- Review
- 15 days
- Class
- Class II
- Product code
- IZI
- Recalls
- 25
- Predicates
- 1
Its longest line of descent runs back 4 generations to K890348 (1989). 7 ancestors in all. 113 later devices descend from it, 2 citing it directly. 10 of the 121 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 3 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 2 generations backK020055 Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 2002 · Recalled
- 1 generation backK022899 Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002 · Recalled
- This deviceK031333 Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003
- Descendant · cites it directly · 64 of its ownK041949 Allura Xper FD10Philips Medical Systems North America Co. · 2004 · Recalled
- Descendant · cites it directly · 51 of its ownK031836 Philips Fresco Release 1Philips Medical Systems North America Co. · 2003
- Descendant · 2 generations on · 49 of its ownK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
- Descendant · 3 generations on · 41 of its ownK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
- Descendant · 4 generations on · 39 of its ownK111245 Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011
Showing 5 of 113 descendants. See all descendants
Descendants cleared per year
2003high 15 (2025) · low 0 (2005)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 113 · See all- K041949Allura Xper FD10Philips Medical Systems North America Co. · 2004 · cites it directly64descendants
- K031836Philips Fresco Release 1Philips Medical Systems North America Co. · 2003 · cites it directly51descendants
- K062650EP Navigator SoftwarePhilips Medical Systems · 2006 · 2 generations on49descendants
- K101311EP Navigator R3Philips Medical Systems North America Co. · 2010 · 3 generations on41descendants
- K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011 · 4 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −3 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −2 | K020055 | Philips Integris Allura 9 with FD Option | Philips Medical Systems | 2002 | 2 |
| −1 | K022899 | Philips Integris Allura Flat Detector Release 1.0 | Philips Medical Systems North America Co. | 2002 | 8 |
| 0 (this device) | K031333 | Philips Integris Allura Flat Detector Release 1.2 | Philips Medical Systems North America, Inc. | 2003 | — |
| +1 | K041949 | Allura Xper FD10 | Philips Medical Systems North America Co. | 2004 | 48 |
| +1 | K031836 | Philips Fresco Release 1 | Philips Medical Systems North America Co. | 2003 | — |
| +2 | K062650 | EP Navigator Software | Philips Medical Systems | 2006 | — |
| +3 | K101311 | EP Navigator R3 | Philips Medical Systems North America Co. | 2010 | — |
| +4 | K111245 | Heartnavigator Release 1 | Philips Medical Systems Nederland B.V. | 2011 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 1 |
| 2014 | 9 | 0 |
| 2015 | 2 | 0 |
| 2016 | 7 | 1 |
| 2017 | 5 | 2 |
| 2018 | 7 | 0 |
| 2019 | 2 | 1 |
| 2020 | 5 | 1 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 6 | 1 |
| 2024 | 8 | 2 |
| 2025 | 15 | 1 |
| 2026 | 11 | 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? (2)
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 |
|---|---|---|---|
| * | K022899 | Philips Integris Allura Flat Detector Release 1.0 | 2002 |
| * | — | GE Innova 4100 system Named without a submission number |
What descends from it? (113)
See all 1132 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (10 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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… |
| Jan 2, 2024 | Class II | Z-1151-2024 | Process design | Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure. |
| 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-3213-2018 | 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-3214-2018 | 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-3217-2018 | 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-3220-2018 | 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-3219-2018 | 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-3215-2018 | 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-3218-2018 | 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-3216-2018 | 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-1820-2017 | 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… |
| 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… |
| Sep 24, 2014 | Class II | Z-1280-2016 | Device Design | Loss of key image functionality due to a bent pedal of the Footswitch. |
| Apr 2, 2012 | Not classified | Z-1462-2012 | Process control | The monitor Ceiling suspension may fail, which may cause the monitor to drop. |
| 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. |
| Feb 4, 2010 | Not classified | Z-2449-2010 | Software design | A lock-up might occur inside the Velara Generator due to intermittent shorts inside the system. The problem can only resolved by a warm or cold system restart. In exceptional cases the power converters of the KVmA unit in the generator… |
| Dec 10, 2008 | Not classified | Z-0344-2009 | Radiation Control for Health and Safety Act | Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch. |
| Oct 23, 2008 | Not classified | Z-2471-2010 | Other | A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the display. |
| Dec 14, 2006 | Not classified | Z-0370-2007 | Other | Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested. |
| Oct 12, 2006 | Not classified | Z-0165-2007 | Other | Potential for generator to lock-up. Fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue. |
| Feb 6, 2006 | Not classified | Z-0581-06 | Other | Potential lock-up of system requiring reboot of system. |
| Oct 12, 2005 | Not classified | Z-0206-06 | Other | Potential for high voltage exposure involving the injector interface connector of patient support tables. |
| Oct 12, 2005 | Not classified | Z-0207-06 | Other | Potential for high voltage exposure involving the injector interface connector of patient support tables. |
The 5 latest of 25 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 · 2 generations on · ◆ 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 · 6 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 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 7 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 · 7 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 · 7 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 · 7 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 8 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 14 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 7 ancestors have a recall of any class.
- Of its descendants, K041949 (Philips Medical Systems North America Co., 2004) has gone furthest, with 64 descendants of its own.
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 Philips lntegris Allura Flat Detector release 1.2 system is intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, intewentional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031333 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031333: Philips Integris Allura Flat Detector Release 1.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031333
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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