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

    VIZION DR

    K Number: K112661 · Decision Oct 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    6
    Review Days
    37

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    Basic Information

    Device Name
    VIZION DR
    K Number
    K112661
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Viztek, LLC
    Date Received
    September 13, 2011
    Decision Date
    October 20, 2011
    Product Code
    MQB
    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
    MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

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    Other Clearances by Viztek, LLC

    K Number Device Name
    K160810 ViZion DR + Wireless
    K152279 ViZion DR + Wireless
    K142919 EXA
    K133139 VIZION ULTRA
    K123644 VIZION + DR