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 Azurion series can be used in a hybrid Operating Room.
The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.

Device Description

The Azurion R3.1 is classified as an interventional fluoroscopic X-Ray system. The primary performance characteristics of the Azurion R3.1 include:

Real-time image visualization of patient anatomy during procedures
Imaging techniques and tools to assist interventional procedures
Post processing functions after interventional procedures
Storage of reference/control images for patient records
Compatibility with hospital information systems (HIS) and image archiving systems via DICOM
Built in radiation safety controls.

The only changes to the subject device, Azurion R3.1 includes the design change to the mattress accessory for all the existing mattresses of the predicate device (Azurion R3.1, K251827, 24 October 2025) and introduction of new gray color mattress. The change includes the addition of a hook and loop fastener (Velcro) solution for use between the mattress and the system integrated patient table (AD7X), to ensure that the mattress does not slip from the patient table.

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - Azurion R3.1

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.02

January 16, 2026

Philips Medical Systems B.V.
℅ Supriya Dalvi
Principal Regulatory Affairs Specialist
Veenpluis 6
Bldg. Qp
Best, Noord-Brabant 5684PC
NETHERLANDS

Re: K254186
Trade/Device Name: Azurion R3.1
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-intensified fluoroscopic x-ray system
Regulatory Class: Class II
Product Code: OWB, JAA
Dated: December 23, 2025
Received: December 23, 2025

Dear Supriya Dalvi:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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K254186 - Supriya Dalvi
Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K254186 - Supriya Dalvi
Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiological Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K254186
Device Name: Azurion R3.1

Indications for Use (Describe)

The Azurion 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 Azurion series can be used in a hybrid Operating Room.
The Azurion 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.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

Azurion R3.1 Special 510(k) - 510(k) Summary

Philips IGTS
Page 1 of 5

510(k) Summary

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

Date Prepared: December 23rd, 2025

Manufacturer: Philips Medical Systems Nederland B.V.
Veenpluis 6,
5684 PC Best
The Netherlands
Establishment Registration Number: 3003768277

Primary Contact Person:	Secondary contact Person:
Dr. Supriya A. Dalvi, PhDRegulatory Affairs Specialist, IGT-S FixedTel: +31 (0) 628945536E-mail: supriya.dalvi@philips.com	Daniela ZaczekDirector of Regulatory Affairs, IGT-S FixedTel: +31 (0) 628517824Email: Daniela.Zaczek@philips.com

Device:	Predicate Device:
Trade Name: Azurion R3.1Classification Name: Image-intensified fluoroscopic x-ray systemClassification Regulation: 21 CFR §892.1650Classification Panel: RadiologyDevice Class: Class IIProduct Code: Primary Code: OWB; Subsequent Code: JAA	Trade Name: Azurion R3.1Manufacturer: Philips Medical Systems Nederland B.V.510(k) Clearance: K251827 (cleared on 24 Oct 2025)Classification Name: Image-intensified fluoroscopic x-ray systemClassification Regulation: 21 CFR §892.1650Classification Panel: RadiologyDevice Class: Class IIProduct Code: Primary Code: OWB; Subsequent Code: JAA

Page 6

Azurion R3.1 Special 510(k)
510(k) Summary
Philips IGTS
Page 2 of 5

Device description: The Azurion R3.1 is classified as an interventional fluoroscopic X-Ray system. The primary performance characteristics of the Azurion R3.1 include:

Real-time image visualization of patient anatomy during procedures
Imaging techniques and tools to assist interventional procedures
Post processing functions after interventional procedures
Storage of reference/control images for patient records
Compatibility with hospital information systems (HIS) and image archiving systems via DICOM
Built in radiation safety controls.

Indications for Use:

The Azurion 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 Azurion series can be used in a hybrid Operating Room.
The Azurion 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.

The indications for use of subject device, Azurion R3.1 with mattress changes are the same as the indications for use of the predicate device (Azurion R3.1, K251827, 24 October 2025).

Technological characteristics:

Azurion R3.1 has the same fundamental technological characteristics as compared to the predicate device (Azurion R3.1, K251827, 24 October 2025).

The only change to the subject device, Azurion R3.1 includes the design change to the mattress accessory. It includes the addition of a hook and loop fastener (Velcro) solution for use between the mattress and the system integrated patient table (AD7X), to ensure that the mattress does not slip from the patient table. This hook and loop fastener solution will be added to all existing mattresses (Yellow, green, blue) of the predicate device (Azurion R3.1, K251827, 24 October 2025). In addition,

Page 7

Azurion R3.1 Special 510(k)
510(k) Summary
Philips IGTS
Page 3 of 5

a new gray color mattress will be released also incorporating the same hook and loop fastener (Velcro) solution as the other mattresses.

The outcome of the technological characteristics comparison and risk assessment demonstrate that the change made to the subject device, Azurion R3.1, does not raise any new questions regarding safety or effectiveness thus demonstrating the substantial equivalence of the subject device, Azurion R3.1, with the predicate device (Azurion R3.1, K251827, 24 October 2025).

Summary of Non-Clinical Performance Data:

Non-clinical performance testing has been performed on the subject device, Azurion R3.1 and the associated change. The test results demonstrates compliance with the following International and FDA-recognized consensus standards:

IEC 60601-2-43 Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures, Edition 2.2 2019-10, Recognition Number 12-329.
IEC 60601-2-28 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis, Edition 3.0 2017, Recognition Number 12-309.
IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic Compatibility – Requirements and tests, Edition 4.1 2020, Recognition number 19-36.
IEC TS 60601-4-2 Medical electrical equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance medical electrical equipment and medical electrical systems, Edition 1.0 2024, Recognition Number 19-50.
IEC 62304 Medical device software – Software life cycle processes, Edition 1.1 2015, Recognition number 13-79.
IEC 62366-1 Medical devices - Part 1: Application of Usability Engineering to Medical Devices, Edition 1.1 2020, Recognition number 5-129.
ISO 14971 Medical devices – Application of risk management to medical devices, Edition 3.0 corrected version 2019, Recognition number 5-125.
IEC 61910-1 Medical electrical equipment – Radiation dose documentation – Part 1: Radiation dose structured reports for radiography and radioscopy, Edition 1.0 2014, Recognition Number 12-290.
NEMA XR-27 X-ray equipment for interventional procedures – User quality control mode, Edition 1.1 Amendment 1-2013, Recognition Number 12-286.
ISO 15223-1 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements, Fourth edition 2021-07, Recognition Number 5-134.
ISO 20417 Medical devices - Information to be supplied by the manufacturer, First edition 2021-04 Corrected version 2021-12, Recognition Number 5-135.

Page 8

Azurion R3.1 Special 510(k)
510(k) Summary
Philips IGTS
Page 4 of 5

ISO 17664-2 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices, First edition 2021-02, Recognition Number 14-579.
IEC 60601-2-54 Medical Electrical Equipment- Part 2-54: Particular Requirements for the Basic Safety and Essential Performance of X-Ray Equipment for Radiography and Radioscopy, Edition 1.1 2009 + A1:2015 + A2:2018.
IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, Edition 3.1 2005 + C1:2006 + C2:2007 + A1:2012.
IEC 60601-1-3 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment, Edition 2.1 2008 + A1:2013.
IEC 60601-1-6 Medical Electrical Equipment Part 1-6: General Requirements for Basic Safety and Essential Performance- Collateral Standard: Usability, Edition 3.1 2010 + A1:2013.
DICOM Edition 2023
21CFR Subchapter J 1020.30 Diagnostic x-ray systems and their major components.
21CFR Subchapter J 1020.32 Fluoroscopic equipment.

Non-clinical verification testing of the functional and non-functional requirements as well as performance, reliability and safety has been successfully performed to verify that all the requirements of System Requirements Specification as well as the safety risk control measures from the Risk Management Matrix have been implemented.

Non-clinical validation testing has been performed to validate that the subject device, Azurion R3.1 conforms to the intended use, claims, user needs, effectiveness of safety measures and instructions for use.

All these tests were used to support substantial equivalence of the subject device and demonstrate that the subject device, Azurion R3.1:

Complies with the aforementioned FDA recognized consensus standards.
Meets the acceptance criteria and is adequate for its intended use.

Therefore, the subject device, Azurion R3.1 is substantially equivalent to the predicate device (Azurion R3.1, K251827, 24 October 2025) in terms of safety and effectiveness.

Page 9

Azurion R3.1 Special 510(k)
510(k) Summary
Philips IGTS
Page 5 of 5

Summary of Clinical Performance Data

The subject device, Azurion R3.1 did not require clinical study since substantial equivalence to the predicate device (Azurion R3.1, K251827, 24 October 2025) was demonstrated with the following attributes:

Indications for use;
Technological characteristics;
Non-clinical performance testing; and
Safety and effectiveness.

Substantial Equivalence Conclusion:

The subject device, Azurion R3.1 is substantially equivalent to the predicate device (Azurion R3.1, K251827, 24 October 2025) in terms of indications for use, technological characteristics and safety and effectiveness.

Additionally, substantial equivalence was demonstrated by non-clinical performance tests provided in this 510(k) premarket notification. These tests demonstrate that Azurion R3.1 complies with the system level requirements, user needs and international and FDA-recognized consensus standards, and is as safe and effective as its predicate device (Azurion R3.1, K251827, 24 October 2025), without raising any new safety and/or effectiveness concerns.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.