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510(k) Data Aggregation

    K Number
    K973125
    Device Name
    MAMMOLOADER BY C.M.A. SRL
    Manufacturer
    Date Cleared
    1997-10-08

    (49 days)

    Product Code
    Regulation Number
    892.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    C.M.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MAMMOLOADER is a device designed to unload and or load medical imaging films from the KODAK Mammography film cassettes (18x24 cm & 24x30 cm) and KODAK Video Film Holder (8x10 in), under roomlight conditions. Two versions are available; integrated with a medical imaging film processor so that when film cassettes are unloaded the film is sent directly into the film processor, or in a stand-alone version in which exposed films are unloaded from cassettes and placed into a receive magazine for processing at a later time.
    Device Description
    The MAMMOLOADER will be used to unload and or load medical imaging films from the KODAK Mammography film cassettes (18x24 cm & 24x30 cm) and KODAK Video Film Holder (8x10 in), under roomlight conditions. Two versions are available; integrated with a medical imaging film processor so that when film cassettes are unloaded the film is sent directly into the film processor, or in a stand-alone version in which exposed films are unloaded from cassettes and placed into a receive magazine for processing at a later time.
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