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

    SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD

    K Number: K141346 · Decision Jun 26, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    120
    Applicant Total
    8
    Review Days
    35

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    Basic Information

    Device Name
    SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD
    K Number
    K141346
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2040
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sony Electronics, Inc.
    Date Received
    May 22, 2014
    Decision Date
    June 26, 2014
    Product Code
    LMC
    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
    LMC Camera, Multi Format, Radiological

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