# K163715: Allura Xper R9

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Jan 26, 2017 after 27 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 12 (7 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K801623 (1980). 54 ancestors in all.
7 later devices descend from it; 1 cites it directly.
4 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162148: Allura Xper R9, Philips Medical Systems Nethrlands BV (2016) Summary page 4.

## Most influential descendants
- K172822: Azurion series R1.2 (2017), 6 descendants of its own
- K181830: Azurion R2.0 (2018), 5 descendants of its own
- K200917: Azurion R2.1 (2020), 4 descendants of its own
- K251827: Azurion R3.1 (2025), 1 descendant of its own
- K243376: uAngio AVIVA CX (2025), 1 descendant of its own

## Recalls of this device
- Jul 16, 2026 · Class II · Z-2931-2026: Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) 
- Aug 1, 2025 · Class II · Z-2503-2025: 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.
- Jun 4, 2025 · Class II · Z-2134-2025: Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
- Jan 13, 2025 · Class I · Z-1159-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1154-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1157-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1142-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1153-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1158-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1160-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- 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.
- Aug 15, 2023 · Class II · Z-2587-2023: A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.

## Indications for use
The Allura Xper R9 series (within the limits of the used Operating Room table) are intended for use to perform: • Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. • Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: • The Allura Xper R9 series can be used in a hybrid Operating Room. • The Allura Xper R9 series contain a number of features to support a flexible and patient centric procedural workflow. Patient Population: All human patients of all ages. Patient weight is limited to the specification of the patient table.

Source page: https://510kreport.com/device/K163715
Methodology: https://510kreport.com/methodology