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

    MXU-125 OR TMX-125

    K Number: K992229 · Decision Aug 6, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    235
    Applicant Total
    6
    Review Days
    35

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    Basic Information

    Device Name
    MXU-125 OR TMX-125
    K Number
    K992229
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trex Medical Corp.
    Date Received
    July 2, 1999
    Decision Date
    August 6, 1999
    Product Code
    IZL
    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
    IZL System, X-Ray, Mobile

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    Other Clearances by Trex Medical Corp.

    K Number Device Name
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    K984414 XRE COLLIMATOR WITH SPECTRAL FILTER
    K982427 TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C
    K982120 DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY)