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

    XRE COLLIMATOR WITH SPECTRAL FILTER

    K Number: K984414 · Decision Dec 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    22
    Applicant Total
    6
    Review Days
    20

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    Basic Information

    Device Name
    XRE COLLIMATOR WITH SPECTRAL FILTER
    K Number
    K984414
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1610
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Trex Medical Corp.
    Date Received
    December 10, 1998
    Decision Date
    December 30, 1998
    Product Code
    IZW
    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
    IZW Collimator, Automatic, Radiographic

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    Other Clearances by Trex Medical Corp.

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