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510(k) Data Aggregation

    K Number
    K013138
    Device Name
    ADC COMPACT PLUS
    Manufacturer
    AGFA-GEVAERT AG
    Date Cleared
    2001-09-28

    (9 days)

    Product Code
    MQB, MOB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    AGFA-GEVAERT AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ADC Compact Plus is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The ADC Compact Plus is intended to be used mainly in chest, skeletal, and gastro-intestinal x-ray imaging applications.
    Device Description
    The ADC Compact Plus is similar to the ADC Compact, but it has a different laser and smaller spot size for improved resolution and higher sensitivity. An improved detector improves the throughout. The electronics are being reorganized and made smaller, which will result in lower power requirements. However, the basic principles of operation are unchanged. The components that implement these principles of operation are simply being upgraded with better components that are now available.
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