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

    PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000

    K Number: K984092 · Decision Feb 5, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    175
    Applicant Total
    6
    Review Days
    81

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    Basic Information

    Device Name
    PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000
    K Number
    K984092
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trex Medical Corp.
    Date Received
    November 16, 1998
    Decision Date
    February 5, 1999
    Product Code
    IZH
    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
    IZH System, X-Ray, Mammographic

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    Other Clearances by Trex Medical Corp.

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    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)