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510(k) Data Aggregation

    K Number
    K241505
    Device Name
    DRX-Revolution Mobile X-ray System
    Manufacturer
    Carestream Health Inc.
    Date Cleared
    2024-12-10

    (196 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    Carestream Health Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.
    Device Description
    The DRX-Revolution Mobile X-ray System is a mobile diagnostic x-ray system that utilizes digital technology for bedside or portable exams. Key components of the system are the x-ray generator, a tube head assembly (includes the x-ray tube and collimator) that allows for multiple axes of movement, a maneuverable drive system, touchscreen user interface(s) for user input. The system is designed with installable software for acquiring and processing medical diagnostic images outside of a standard stationary X-ray room. It is a mobile diagnostic system intended to generate and control X-rays for examination of various anatomical regions.
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    K Number
    K191025
    Device Name
    DRX-Revolution Mobile X-ray System
    Manufacturer
    Carestream Health Inc.
    Date Cleared
    2019-05-17

    (29 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    Carestream Health Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is designed to perform radiographic x-ray examinations on all pediatric and adult patient treatment areas.
    Device Description
    The DRX-Revolution Mobile X-ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. The system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of a standard stationary xray room. The DRX-Revolution system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The system can also be used to expose CR phosphor screens or films.
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