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510(k) Data Aggregation

    K Number
    K093596
    Device Name
    LUMOS, MODEL R 72B
    Manufacturer
    LUMOS, INC
    Date Cleared
    2010-01-12

    (53 days)

    Product Code
    KPW
    Regulation Number
    892.1610
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMOS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Model R 72B Manual X-RAY Collimator is intended for use in diagnostic radiographic or fluoroscopic applications fluoroscopic applications.
    Device Description
    This is a compact collimator with an external cover in ABS plastic. It is a single-layer, square field radiological collimator. Its light weight and compact size allow cass. positioning and make it ideal for mobile and portable units. The X-ray field size is limited by two pairs of lead shutters controlled by two knobs located on the sides of the collimator and by o yead disc near the x-ray focus to reduce scattered radiation. An indexed scale provides information on the field set with the knobs.
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