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

    DIAGNOSTICPRO EDGE

    K Number: K130406 · Decision Apr 29, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    60
    Applicant Total
    13
    Review Days
    69

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    Basic Information

    Device Name
    DIAGNOSTICPRO EDGE
    K Number
    K130406
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2030
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vidar Systems Corp.
    Date Received
    February 19, 2013
    Decision Date
    April 29, 2013
    Product Code
    LMA
    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
    LMA Digitizer, Image, Radiological

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    Other Clearances by Vidar Systems Corp.

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    K011049 EXPRESSSUITE
    K993598 MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205
    K993599 DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019
    K993597 PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617
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