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

    5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION

    K Number: K031929 · Decision Jul 8, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    8
    Review Days
    15

    Basic Information

    Device Name
    5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION
    K Number
    K031929
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    WIDE CORPORATION
    Date Received
    June 23, 2003
    Decision Date
    July 8, 2003
    Product Code
    LLZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LLZ System, Image Processing, Radiological

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    Other Clearances by WIDE CORPORATION

    K Number Device Name
    K160354 MX50T(MX50TQS)
    K160348 CX30N (CX30PQX)
    K110596 MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM
    K052312 WIDE 5MP (MAMMO) LCD MONITOR SYSTEM
    K042634 WIDE 1MP LCD MONITOR SYSTEM
    K032960 WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A
    K032174 WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A