BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MC2 Portable X-ray System

    K Number: K252068 · Decision Dec 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    319
    Applicant Total
    2
    Review Days
    174

    Basic Information

    Device Name
    MC2 Portable X-ray System
    K Number
    K252068
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oxos Medical
    Date Received
    July 1, 2025
    Decision Date
    December 22, 2025
    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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