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510(k) Data Aggregation

    K Number
    K251710

    Validate with FDA (Live)

    Device Name
    Mobile X-ray unit (!M1)
    Manufacturer
    Solutions for tomorrow AB
    Date Cleared
    2025-10-24

    (143 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K241980
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

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