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    K Number
    K241980
    Device Name
    !M1
    Manufacturer
    Solutions for tomorrow AB
    Date Cleared
    2025-05-06

    (305 days)

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

    Solutions for tomorrow AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is designed to perform general radiography x-ray examinations on all pediatric and all adult patients, in all patient treatment areas. Treatment areas are defined as professional health care facility environments where operators with medical training are continually present during patients' examinations.
    Device Description
    The !M1 mobile X-ray system is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. The device consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images both inside and outside of a standard stationary x-ray room. The !M1 system incorporates a flat-panel detector(s) that can be used wirelessly for exams such as in-bed projections. The system can also be used to expose CR phosphor screens or film.
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    K Number
    K170607
    Device Name
    !M1
    Manufacturer
    Solutions For Tomorrow AB
    Date Cleared
    2017-07-17

    (138 days)

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

    Solutions For Tomorrow AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is designed to perform general radiography x-ray examinations on all pediatric and all adult patients, in all patient treatment areas. Treatment areas are defined as professional health care facility environments where operators with medical training are continually present during patients' examinations.
    Device Description
    The ModelOne mobile X-ray system is a diagnostic mobile x-ray system utilizing digital radiography technology. The device consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images both inside and outside of a standard stationary x-ray room. The ModelOne system incorporates a flat-panel(s) detector that can be used wirelessly for exams as in-bed projections. The system is intended to be marketed with two options with flat-panel digital images from Canon and Konica Minolta.
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