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

    DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5

    K Number: K984466 · Decision Mar 16, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    129
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5
    K Number
    K984466
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1100
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dilon Technologies, Inc.
    Date Received
    December 16, 1998
    Decision Date
    March 16, 1999
    Product Code
    IYX
    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
    IYX Camera, Scintillation (Gamma)

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