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

    TISSUE-EQUIVALENT BREAST SIMULATOR

    K Number: K865100 · Decision Jan 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    13

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    Basic Information

    Device Name
    TISSUE-EQUIVALENT BREAST SIMULATOR
    K Number
    K865100
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1940
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Computerized Imaging Reference Systems, Inc.
    Date Received
    December 30, 1986
    Decision Date
    January 12, 1987
    Product Code
    IXF
    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
    IXF Test-Pattern, Radiographic

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    Other Clearances by Computerized Imaging Reference Systems, Inc.

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