BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BONE DENSITY CT PHANTOM

    K Number: K852528 · Decision Sep 26, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    104

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    Basic Information

    Device Name
    BONE DENSITY CT PHANTOM
    K Number
    K852528
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1950
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Computerized Imaging Reference Systems, Inc.
    Date Received
    June 14, 1985
    Decision Date
    September 26, 1985
    Product Code
    IXG
    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
    IXG Phantom, Anthropomorphic, Radiographic

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