# K130638: Alluraclarity Xper FD Series X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Jun 28, 2013 after 109 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 39 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K801623 (1980). 50 ancestors in all.
18 later devices descend from it; 2 cite it directly.
5 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102005: Allura Xper or Table Series, Philips Medical Systems North America, Inc. (2010) Summary page 1.
- K041949: Allura Xper FD10, Philips Medical Systems North America Co. (2004) Summary page 1.
- K033737: Allura Xper FD20, Philips Medical Systems North America, Inc. (2003) Summary page 1.

## Most influential descendants
- K133292: Allura Xper FD; or Table (2014), 15 descendants of its own
- K141979: Allura Xper FD Series / Allura Xper or Table Series (2014), 13 descendants of its own
- K162148: Allura Xper R9 (2016), 8 descendants of its own
- K163715: Allura Xper R9 (2017), 7 descendants of its own
- K172822: Azurion series R1.2 (2017), 6 descendants of its own

## Recalls of this device
- Jun 17, 2026 · Class II · Z-2891-2026: 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: 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: 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
- Apr 30, 2026 · Class II · Z-2259-2026: 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
- Apr 30, 2026 · Class II · Z-2258-2026: 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
- Dec 15, 2025 · Class II · Z-1062-2026: 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
- Dec 15, 2025 · Class II · Z-1063-2026: 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
- Dec 15, 2025 · Class II · Z-1065-2026: 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
- Dec 15, 2025 · Class II · Z-1066-2026: 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
- Dec 15, 2025 · Class II · Z-1067-2026: 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
- Dec 15, 2025 · Class II · Z-1071-2026: 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
- Dec 15, 2025 · Class II · Z-1072-2026: 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
- Dec 15, 2025 · Class II · Z-1074-2026: 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
- Dec 15, 2025 · Class II · Z-1077-2026: 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
- Dec 15, 2025 · Class II · Z-1076-2026: 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
- Dec 15, 2025 · Class II · Z-1064-2026: 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
- Dec 15, 2025 · Class II · Z-1075-2026: 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
- Dec 15, 2025 · Class II · Z-1069-2026: 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
- Dec 15, 2025 · Class II · Z-1070-2026: 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
- Dec 15, 2025 · Class II · Z-1073-2026: 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
- Dec 15, 2025 · Class II · Z-1068-2026: 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
- Sep 3, 2025 · Class II · Z-2624-2025: 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 movem
- Sep 3, 2025 · Class II · Z-2634-2025: 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 movem
- Sep 3, 2025 · Class II · Z-2626-2025: 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 movem
- Sep 3, 2025 · Class II · Z-2625-2025: 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 movem
- Sep 3, 2025 · Class II · Z-2629-2025: 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 movem
- Sep 3, 2025 · Class II · Z-2635-2025: 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 movem
- Sep 3, 2025 · Class II · Z-2628-2025: 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 movem
- Sep 3, 2025 · Class II · Z-2633-2025: 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 movem
- Sep 3, 2025 · Class II · Z-2623-2025: 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 movem
- Sep 3, 2025 · Class II · Z-2630-2025: 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 movem
- Sep 3, 2025 · Class II · Z-2632-2025: 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 movem
- Sep 3, 2025 · Class II · Z-2631-2025: 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 movem
- Sep 3, 2025 · Class II · Z-2627-2025: 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 movem
- Aug 1, 2025 · Class II · Z-2504-2025: 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: 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: 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 
- Jan 2, 2024 · Class II · Z-1151-2024: 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: The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.

## Indications for use
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.

Source page: https://510kreport.com/device/K130638
Methodology: https://510kreport.com/methodology