510(k) · Cleared
Recalled · Class II · 2026Allura Xper or Table Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Aug 9, 2010 as substantially equivalent to K002016 (Philips Medical Systems North America, Inc., 2000) and 5 other predicates after a 25-day review. Its family tree reaches back 8 generations to 1980. 5 of the 74 devices in its family, counting itself, have a Class I recall. 24 later devices descend from it. It has been recalled 39 times.
- Decided
- Aug 9, 2010
- Review
- 25 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 39
- Predicates
- 6
Its longest line of descent runs back 8 generations to K801623 (1980). 49 ancestors in all. 24 later devices descend from it, 4 citing it directly. 5 of the 74 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 7 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 6 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 5 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 4 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 3 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 1 generation backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- This deviceK102005 Allura Xper or Table SeriesPhilips Medical Systems North America, Inc. · 2010
- Descendant · cites it directly · 18 of its ownK130638 Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V. · 2013 · Recalled
- 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)
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
2013high 5 (2016) · low 0 (2015)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 24 · See all- 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 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −7 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −6 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −5 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −4 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −3 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −2 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −1 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| 0 (this device) | K102005 | Allura Xper or Table Series | Philips Medical Systems North America, Inc. | 2010 | — |
| +1 | K130638 | Alluraclarity Xper FD Series X-Ray System | Philips Medical Systems Nederland B.V. | 2013 | 39 |
| +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 |
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 |
|---|---|---|
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2016 | 5 | 1 |
| 2017 | 2 | 2 |
| 2018 | 2 | 0 |
| 2020 | 1 | 1 |
| 2021 | 1 | 0 |
| 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 18.3 · 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? (6)
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 |
|---|---|---|---|
| * | K002016 | Philips Integris AlluraSummary page 1…Axiom Arlis, Siemens Artis Zee family, Siemens Artis Zee / Zeego family Manufacturer:........c..ceeenivennnnne Philips and Siemens 510(k) numbers:..........ccceeinnnen. K002016, K041949, K033737, K021021, K073290, K090745 510(k) Summary, Allura Xper FD OR Table series Page 10of3 Philips M… | 2000 |
| * | K041949 | Allura Xper FD10Summary page 1…is, Siemens Artis Zee family, Siemens Artis Zee / Zeego family Manufacturer:........c..ceeenivennnnne Philips and Siemens 510(k) numbers:..........ccceeinnnen. K002016, K041949, K033737, K021021, K073290, K090745 510(k) Summary, Allura Xper FD OR Table series Page 10of3 Philips Medical Sy… | 2004 |
| * | K033737 | Allura Xper FD20Summary page 1…ns Artis Zee family, Siemens Artis Zee / Zeego family Manufacturer:........c..ceeenivennnnne Philips and Siemens 510(k) numbers:..........ccceeinnnen. K002016, K041949, K033737, K021021, K073290, K090745 510(k) Summary, Allura Xper FD OR Table series Page 10of3 Philips Medical Systems Ned… | 2003 |
| * | K021021 | Modular Angiography System Axiom ArtisSummary page 1…Zee family, Siemens Artis Zee / Zeego family Manufacturer:........c..ceeenivennnnne Philips and Siemens 510(k) numbers:..........ccceeinnnen. K002016, K041949, K033737, K021021, K073290, K090745 510(k) Summary, Allura Xper FD OR Table series Page 10of3 Philips Medical Systems Nederiand B.… | 2002 |
| * | K073290 | Artis Zee and ZeegoSummary page 1…y, Siemens Artis Zee / Zeego family Manufacturer:........c..ceeenivennnnne Philips and Siemens 510(k) numbers:..........ccceeinnnen. K002016, K041949, K033737, K021021, K073290, K090745 510(k) Summary, Allura Xper FD OR Table series Page 10of3 Philips Medical Systems Nederiand B.V. The Na… | 2008 |
| * | K090745 | Artis Zee / Zeegos with SW VC14Summary page 1…s Artis Zee / Zeego family Manufacturer:........c..ceeenivennnnne Philips and Siemens 510(k) numbers:..........ccceeinnnen. K002016, K041949, K033737, K021021, K073290, K090745 510(k) Summary, Allura Xper FD OR Table series Page 10of3 Philips Medical Systems Nederiand B.V. The Natherlands… | 2009 |
What descends from it? (24)
See all 244 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. |
| Aug 1, 2025 | Class II | Z-2503-2025 | Under Investigation by firm | Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost. |
| 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… |
| Nov 3, 2015 | Class II | Z-0765-2016 | Device Design | Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances, when the C-arc is initially stopped… |
| Jun 6, 2014 | Class II | Z-1120-2015 | Radiation Control for Health and Safety Act | In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound. |
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 30 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 15 of the 49 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K130638 (Philips Medical Systems Nederland B.V., 2013) has gone furthest, with 18 descendants of its own.
- 2 other devices also cite its predicate K002016.
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. 2010, 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 Allura Xper OR Table Series Is intended for use on human patlents (within the limits of the used OR table) to perform: * Vascular and neurovascular imaging applications, Including dlagnostic, interventional and minimally Invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal anglography, as well as PTAs, stent placements, embolisations and thrombolysis. * Cardiac Imaging applications including diagnostics…
Read the full statement (132 words)
The Allura Xper OR Table Series Is intended for use on human patlents (within the limits of the used OR table) to perform:
* Vascular and neurovascular imaging applications, Including dlagnostic, interventional and minimally Invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal anglography, 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 Interventlons such as drainages, biopsies and vertebroplasties procedures,
Combined with a qualified, compatible OR table, the Allura Xper OR Table Series can be used for imaging in the Hybrid OR within the applications domalns Neuro, Vascular, Non Vascular and Cardlac. The OR table can also be used standalone for surgical use In the OR.
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/K102005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102005: Allura Xper or Table Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102005
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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