510(k) · Cleared
Recalled · 2010Philips Integris Allura Flat Detector Release 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America Co. · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Nov 22, 2002 as substantially equivalent to K020055 (Philips Medical Systems, 2002) after an 80-day review. Its family tree reaches back 3 generations to 1989. 10 of the 121 devices in its family, counting itself, have a Class I recall. 114 later devices descend from it. It has been recalled 8 times.
- Decided
- Nov 22, 2002
- Review
- 80 days
- Class
- Class II
- Product code
- JAA
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 3 generations to K890348 (1989). 6 ancestors in all. 114 later devices descend from it, 1 citing it directly. 10 of the 121 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 2 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 1 generation backK020055 Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 2002 · Recalled
- This deviceK022899 Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002
- Descendant · cites it directly · 113 of its ownK031333 Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 64 of its ownK041949 Allura Xper FD10Philips Medical Systems North America Co. · 2004 · Recalled
- Descendant · 2 generations on · 51 of its ownK031836 Philips Fresco Release 1Philips Medical Systems North America Co. · 2003
- Descendant · 3 generations on · 49 of its ownK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
- Descendant · 4 generations on · 41 of its ownK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
Showing 5 of 114 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 114 · See all- K031333Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · cites it directly113descendants
- K041949Allura Xper FD10Philips Medical Systems North America Co. · 2004 · 2 generations on64descendants
- K031836Philips Fresco Release 1Philips Medical Systems North America Co. · 2003 · 2 generations on51descendants
- K062650EP Navigator SoftwarePhilips Medical Systems · 2006 · 3 generations on49descendants
- K101311EP Navigator R3Philips Medical Systems North America Co. · 2010 · 4 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −2 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −1 | K020055 | Philips Integris Allura 9 with FD Option | Philips Medical Systems | 2002 | 2 |
| 0 (this device) | K022899 | Philips Integris Allura Flat Detector Release 1.0 | Philips Medical Systems North America Co. | 2002 | — |
| +1 | K031333 | Philips Integris Allura Flat Detector Release 1.2 | Philips Medical Systems North America, Inc. | 2003 | 25 |
| +2 | K041949 | Allura Xper FD10 | Philips Medical Systems North America Co. | 2004 | 48 |
| +2 | K031836 | Philips Fresco Release 1 | Philips Medical Systems North America Co. | 2003 | — |
| +3 | K062650 | EP Navigator Software | Philips Medical Systems | 2006 | — |
| +4 | K101311 | EP Navigator R3 | Philips Medical Systems North America Co. | 2010 | — |
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 | 2 | 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 JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 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 |
|---|---|---|---|
| * | K020055 | Philips Integris Allura 9 with FD OptionSummary page 1…m with FD Option manufactured by Philips Medical Systems. The Philips Integris Allura 9 system with FD Option received a 510(k) substantially cquivalent determination in K020055 on March 15, 2002. The solid state x-ray imaging device is the same product in both systems. Device description: The Philips I… | 2002 |
What descends from it? (114)
See all 1141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031333 | Philips Integris Allura Flat Detector Release 1.2 | 2003 | 113 |
Has anything in its family been recalled? (10 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 7, 2010 | Not classified | Z-1654-2011 | Nonconforming Material/Component | A wire in the connector of the Generator Grid Switch Supervisor box might short-circuit between 12V power and ground, and it will cause a System breakdown. |
| Feb 4, 2010 | Not classified | Z-2448-2010 | Software design | A lock-up might occur inside the Velara Generator due to intermittent shorts inside the system. The problem could 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-0347-2009 | Radiation Control for Health and Safety Act | Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch. |
| Dec 10, 2008 | Not classified | Z-0350-2009 | 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-2474-2010 | 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. |
| Oct 23, 2008 | Not classified | Z-2477-2010 | 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-0369-2007 | 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. |
| Dec 14, 2006 | Not classified | Z-0368-2007 | 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. |
The 5 latest of 8 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 · 3 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 · 7 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 · 7 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 8 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 · 8 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 · 8 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 · 8 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 9 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 13 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K031333 (Philips Medical Systems North America, Inc., 2003) has gone furthest, with 113 descendants of its own.
- 1 other device also cites its predicate K020055.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, 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 | 1 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Philips Integris Allura Flat Detector release 1.0 system is intended for use in cardiovascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K022899 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022899: Philips Integris Allura Flat Detector Release 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022899
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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