BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    Azurion R3.1

    K Number: K254186 · Decision Jan 16, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    319
    Applicant Total
    2
    Review Days
    24

    Basic Information

    Device Name
    Azurion R3.1
    K Number
    K254186
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems B.V.
    Date Received
    December 23, 2025
    Decision Date
    January 16, 2026
    Product Code
    OWB
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OWB Interventional Fluoroscopic X-Ray System

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    Other Clearances by Philips Medical Systems B.V.

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    K251827 Azurion R3.1