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

    VIDAR VISION 2000

    K Number: K070563 · Decision Mar 16, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    13
    Review Days
    17

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    Basic Information

    Device Name
    VIDAR VISION 2000
    K Number
    K070563
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vidar Systems Corp.
    Date Received
    February 27, 2007
    Decision Date
    March 16, 2007
    Product Code
    MQB
    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
    MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

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    Other Clearances by Vidar Systems Corp.

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    K093809 VIDAR DENTAL FILM DIGITIZER
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    K024171 VIDAR BONE TRACK SYSTEM SOFTWARE
    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
    Search all 13 clearances from Vidar Systems Corp. →