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510(k) Data Aggregation

    K Number
    K220678
    Device Name
    APX-24 Portable X-ray System
    Manufacturer
    Aspenstate INC
    Date Cleared
    2022-03-31

    (23 days)

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

    Aspenstate INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The APX-24 Portable X-ray is intended for use by a qualified/trained physician on both adult and pediatric subjects for taking diagnostic X-rays.
    Device Description
    The APX-24 Portable X-ray is a portable unit that operates from120 V / 220-240V, 50 / 60 Hz. The unit utilizes a newly designed high-frequency inverter and can bemounted to a tripod or support arm. The operator must observe the usual safety precautions regarding the use of x- rays.
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