BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO

    K Number: K000159 · Decision Feb 16, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    13
    Applicant Total
    19
    Review Days
    28

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    Basic Information

    Device Name
    AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO
    K Number
    K000159
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1630
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Agfa Corp.
    Date Received
    January 19, 2000
    Decision Date
    February 16, 2000
    Product Code
    IXK
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IXK System, Imaging, X-Ray, Electrostatic

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