BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    Digital C-ARM with 3D

    K Number: K253296 · Decision Jun 5, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    81
    Applicant Total
    8
    Review Days
    249

    Basic Information

    Device Name
    Digital C-ARM with 3D
    K Number
    K253296
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Allengers Medical Systems Limited
    Date Received
    September 29, 2025
    Decision Date
    June 5, 2026
    Product Code
    OXO
    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
    OXO Image-Intensified Fluoroscopic X-Ray System, Mobile

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