# K162148: Allura Xper R9

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nethrlands BV
- Decided: Nov 23, 2016 after 114 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K801623 (1980). 53 ancestors in all.
8 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)
- K141979: Allura Xper FD Series / Allura Xper or Table Series, Philips Medical Systems Netherland BV (2014) Summary page 4.

## Most influential descendants
- K163715: Allura Xper R9 (2017), 7 descendants of its own
- 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

## Recalls of this device
- Aug 13, 2021 · Class II · Z-2476-2021: Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulate
- Dec 23, 2019 · Class II · Z-1145-2020: Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.
- Aug 18, 2017 · Class II · Z-0255-2018: When using the downscale option with the Allura R9 system or Azurion R1.1 system, the measurements performed using the QA Basic Measurement tool will not be correctly exported to the external DICOM de

## 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/K162148
Methodology: https://510kreport.com/methodology