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Azurion R3.1

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251827

by Philips Medical Systems B.V.

Identifiers

510(k) Number
K251827 FDA 510(k)
FDA Product Code
OWB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1650 FDA 510(k)
Regulation Number
892.1650 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Azurion R3.1 is an Interventional Fluoroscopic X-Ray System, designed for real-time imaging during interventional procedures. It provides high-resolution fluoroscopy and advanced imaging capabilities to support precise guidance in catheterization labs, interventional radiology (IR) suites, and hybrid operating rooms. The system integrates fluoroscopy, angiography, and digital subtraction angiography (DSA) to enhance procedural accuracy and efficiency in cardiology, vascular, and other interventional specialties.

This device is intended for use in clinical settings where fluoroscopic imaging is required, such as cath labs, IR labs, and hybrid ORs. It is supplied as a reusable medical system, adhering to regulatory standards including FDA 510(k) clearance (K251827) and EU regulation 892.1650. The system is not classified as MRI-safe but is designed for interventional procedures where X-ray imaging is essential. No specific sterility or single-use requirements are noted; maintenance and calibration follow manufacturer guidelines to ensure performance and safety.

Frequently asked questions

What is the Azurion R3.1 designed for?

The Azurion R3.1 is an interventional fluoroscopic X-ray system specifically designed for real-time imaging during catheterization lab, interventional radiology (IR), and hybrid operating room procedures. It integrates fluoroscopy, angiography, and digital subtraction angiography (DSA) to enhance procedural accuracy in cardiology, vascular, and other interventional specialties. The system ensures precise guidance by providing high-resolution imaging, which is critical for complex interventions.

How is the Azurion R3.1 supplied and maintained?

The Azurion R3.1 is supplied as a reusable medical system, meaning it is intended for repeated use in clinical settings after proper cleaning, maintenance, and calibration. Philips Medical Systems provides guidelines for maintenance and calibration to ensure optimal performance and safety. This approach aligns with regulatory standards, including FDA 510(k) clearance and EU regulation 892.1650, ensuring compliance and reliability for interventional procedures.

Is the Azurion R3.1 sterile or single-use?

The Azurion R3.1 is not classified as a sterile or single-use device. It is designed as a reusable system, adhering to manufacturer protocols for cleaning, disinfection, and maintenance between uses. Sterility is not applicable to this system, as it is intended for institutional use in controlled clinical environments where proper maintenance procedures are followed.

What regulatory approvals does the Azurion R3.1 hold?

The Azurion R3.1 holds FDA 510(k) clearance under the reference number K251827, indicating it is deemed substantially equivalent to a legally marketed device. Additionally, it complies with EU regulation 892.1650, ensuring it meets the necessary standards for use in European clinical settings. These approvals confirm its safety, effectiveness, and regulatory compliance for interventional imaging procedures.

Where can the Azurion R3.1 be used, and what environments are suitable?

The Azurion R3.1 is intended for use in clinical settings where fluoroscopic imaging is essential, including catheterization labs, interventional radiology (IR) suites, and hybrid operating rooms. These environments require precise imaging for procedures such as cardiology interventions, vascular studies, and other specialized interventional techniques. The system’s advanced imaging capabilities make it suitable for high-precision applications where real-time visualization is critical.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Azurion - Image-guided therapy systems - Philips, Azurion Systeme für die bildgeführte Therapie - Philips, Azurion R3.1 (K251827) — FDA 510 (k) | Innolitics, Philips - Azurion 5 C12 System für die bildgeführte Therapie - Philips, K254186 FDA 510(k) - Azurion R3.1 | Philips Medical Systems B.V.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medical Systems B.V.

Sources (1)

  • FDA 510(k) K251827 24 fields · synced Oct 1, 2026