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

    Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System

    K Number: K253185 · Decision Mar 11, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    235
    Applicant Total
    5
    Review Days
    166

    Basic Information

    Device Name
    Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
    K Number
    K253185
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carestream Health
    Date Received
    September 26, 2025
    Decision Date
    March 11, 2026
    Product Code
    IZL
    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
    IZL System, X-Ray, Mobile

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