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Allura Xper R9

by Philips Medical Systems Nederland B.V.

510(k) K163715

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

12 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK163715 Date26 Jan 2017ClearedStatusActive

Recalls

12 recalls · 12 ongoing · FDA

    • Ongoing Z-2931-2026 FDA Class II initiated 16 Jul 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) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

    • Ongoing Z-2503-2025 FDA Class II initiated 1 Aug 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.

    • Ongoing Z-2134-2025 FDA Class II initiated 4 Jun 2025

    Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.

  • 7 recalls, same reason

    • Ongoing Z-1160-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1159-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1153-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1157-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1158-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1154-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1142-2025 FDA Class I initiated 13 Jan 2025

    Possibility of the patient falling from the table related to the mattress used on the patient table.

    • Ongoing Z-1151-2024 FDA Class II initiated 2 Jan 2024

    Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.

    • Ongoing Z-2587-2023 FDA Class II initiated 15 Aug 2023

    A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OWB
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Allura Xper R9 is an Interventional Fluoroscopic X-Ray System, designed for real-time imaging during minimally invasive procedures. It provides high-resolution fluoroscopy and advanced imaging capabilities to support cardiology, neurology, and vascular interventions, enabling precise visualization of anatomical structures and interventional tools.

This system is intended for use in clinical settings such as catheterization labs, operating rooms, and interventional radiology suites. Supplied as a reusable device, it requires proper sterilization and maintenance protocols. The Allura Xper R9 is FDA-cleared under a 510(k) Special Review (K163715) and complies with regulatory standards for interventional radiology equipment, including registration numbers listed under 21 CFR 892.1650.

Allura Xper R9

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Allura Xper R9 used for?

    The Allura Xper R9 is an interventional fluoroscopic X-ray system designed for real-time imaging during minimally invasive procedures. It supports precise visualization of anatomical structures and interventional tools in specialties like cardiology, neurology, and vascular interventions. This makes it ideal for procedures in catheterization labs, operating rooms, and interventional radiology suites.

  • Is the Allura Xper R9 a single-use or reusable device?

    The Allura Xper R9 is a reusable medical device. As such, it requires proper sterilization and maintenance protocols to ensure safety and performance between uses in clinical settings.

  • What regulatory approval does the Allura Xper R9 hold?

    The Allura Xper R9 is FDA-cleared under a 510(k) Special Review (K163715). It is also compliant with regulatory standards for interventional radiology equipment, including registration under 21 CFR 892.1650. This clearance indicates it meets the FDA’s requirements for safety and effectiveness as a substantially equivalent device.

  • Where can the Allura Xper R9 be used in a clinical setting?

    The Allura Xper R9 is intended for use in specialized clinical environments such as catheterization labs, operating rooms, and interventional radiology suites. Its advanced imaging capabilities make it particularly suited for procedures requiring high-resolution fluoroscopy in cardiology, neurology, and vascular interventions.

  • How does the Allura Xper R9 support interventional procedures?

    The Allura Xper R9 provides high-resolution fluoroscopy and advanced imaging features to enable real-time visualization of anatomical structures and interventional tools. This capability is critical for guiding catheters, stents, and other devices during procedures, ensuring precision and reducing procedural risks in specialties like cardiology and vascular interventions.