510(k) · Cleared
Recalled · Class II · 2026Alluraclarity Xper FD Series X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Jun 28, 2013 as substantially equivalent to K102005 (Philips Medical Systems North America, Inc., 2010) and 2 other predicates after a 109-day review. Its family tree reaches back 9 generations to 1980. 5 of the 69 devices in its family, counting itself, have a Class I recall. 18 later devices descend from it. It has been recalled 39 times.
- Decided
- Jun 28, 2013
- Review
- 109 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 39
- Predicates
- 3
Its longest line of descent runs back 9 generations to K801623 (1980). 50 ancestors in all. 18 later devices descend from it, 2 citing it directly. 5 of the 69 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 5 generations between
- 3 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 2 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 1 generation backK102005 Allura Xper or Table SeriesPhilips Medical Systems North America, Inc. · 2010 · Recalled
- This deviceK130638 Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V. · 2013
- Descendant · cites it directly · 15 of its ownK133292 Allura Xper FD; or TablePhilips Medical Systems Nederland B.V. · 2014 · Recalled
- Descendant · 2 generations on · 13 of its ownK141979 Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV · 2014 · Recalled
- Descendant · 3 generations on · 8 of its ownK162148 Allura Xper R9Philips Medical Systems Nethrlands BV · 2016 · Recalled
- Descendant · 4 generations on · 7 of its ownK163715 Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · Recalled (Class I)
- Descendant · 5 generations on · 6 of its ownK172822 Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · Recalled (Class I)
Show all 9 generations
- Root · 9 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 8 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 7 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 6 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 5 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 4 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 3 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 2 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 1 generation backK102005 Allura Xper or Table SeriesPhilips Medical Systems North America, Inc. · 2010 · Recalled
- This deviceK130638 Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V. · 2013
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
2014high 4 (2014) · low 0 (2015)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 18 · See all- K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V. · 2014 · cites it directly15descendants
- K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV · 2014 · 2 generations on13descendants
- K162148Allura Xper R9Philips Medical Systems Nethrlands BV · 2016 · 3 generations on8descendants
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 4 generations on7descendants
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −8 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −7 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −6 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −5 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −4 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −3 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −2 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| −1 | K102005 | Allura Xper or Table Series | Philips Medical Systems North America, Inc. | 2010 | 39 |
| 0 (this device) | K130638 | Alluraclarity Xper FD Series X-Ray System | Philips Medical Systems Nederland B.V. | 2013 | — |
| +1 | K133292 | Allura Xper FD; or Table | Philips Medical Systems Nederland B.V. | 2014 | 45 |
| +2 | K141979 | Allura Xper FD Series / Allura Xper or Table Series | Philips Medical Systems Netherland BV | 2014 | 81 |
| +3 | K162148 | Allura Xper R9 | Philips Medical Systems Nethrlands BV | 2016 | 3 |
| +4 | K163715 | Allura Xper R9 | Philips Medical Systems Nederland B.V. | 2017 | Class I |
| +5 | K172822 | Azurion series R1.2 | Philips Medical Systems Nederland B.V. | 2017 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 10 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 1 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 4 | 0 |
| 2016 | 4 | 1 |
| 2017 | 2 | 2 |
| 2018 | 1 | 0 |
| 2020 | 1 | 1 |
| 2022 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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.
5 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.2 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K102005 | Allura Xper or Table SeriesSummary page 1…R 892.1650 Regulation Name: Image Intensified fluoroscopic x-ray system Regulatory Class: Class 1 Product Code: OWB Predicate Devices: Allura Xper FD OR Tables Series (K102005) Allura Xper FD10 (K041949) Allura Xper FD20 (K033737) Device Description: The AlluraClarity Xper FD Series X-Ray System (Allur… | 2010 |
| * | K041949 | Allura Xper FD10Summary page 1…Image Intensified fluoroscopic x-ray system Regulatory Class: Class 1 Product Code: OWB Predicate Devices: Allura Xper FD OR Tables Series (K102005) Allura Xper FD10 (K041949) Allura Xper FD20 (K033737) Device Description: The AlluraClarity Xper FD Series X-Ray System (AlluraClarity system) is a modul… | 2004 |
| * | K033737 | Allura Xper FD20Summary page 1…opic x-ray system Regulatory Class: Class 1 Product Code: OWB Predicate Devices: Allura Xper FD OR Tables Series (K102005) Allura Xper FD10 (K041949) Allura Xper FD20 (K033737) Device Description: The AlluraClarity Xper FD Series X-Ray System (AlluraClarity system) is a modular angiographic X-ray syste… | 2003 |
What descends from it? (18)
See all 182 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
| 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. |
| 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-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-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-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-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… |
| 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-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-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-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-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-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-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-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… |
| 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-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-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-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-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-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-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-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-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-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-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… |
| 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. |
| Jan 2, 2024 | Class II | Z-1156-2024 | Process design | Dual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure. |
| Jan 2, 2024 | Class II | Z-1144-2024 | Process design | Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may… |
| 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. |
| Jun 12, 2023 | Class II | Z-2283-2023 | Component design/selection | The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage. |
The 5 latest of 39 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
- K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- The line of descent spans 33 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 16 of the 50 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K133292 (Philips Medical Systems Nederland B.V., 2014) has gone furthest, with 15 descendants of its own.
- 3 other devices also cite its predicate K102005.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2007high 24 (2021) · low 3 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
2007high 221 (2026) · low 37 (2012)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
2007high 42 (2026) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
2007high 14,008 (2025) · low 0 (2008)2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The AlluraClarity Xper FD Series X-ray System is intended 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 (105 words)
The AlluraClarity Xper FD Series X-ray System is intended 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.
Additionally:
- The AlluraClarity Xper FD Series X-ray System is compatible with a hybrid Operating Room.
- FDI10 is compatible with specified magnetic navigation systems.
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/K130638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130638: Alluraclarity Xper FD Series X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130638
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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