BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    CX50N(CX50YQS)

    K Number: K170783 · Decision Mar 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    130
    Applicant Total
    10
    Review Days
    16

    Basic Information

    Device Name
    CX50N(CX50YQS)
    K Number
    K170783
    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
    March 15, 2017
    Decision Date
    March 31, 2017
    Product Code
    PGY
    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
    PGY Display, Diagnostic Radiology

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    Other Clearances by WIDE Corporation

    K Number Device Name
    K222719 CX50N
    K222716 MX50N
    K222722 CW60N
    K222717 CL24N
    K170781 MX50N(MX50YQS)
    K160353 MX50N(MX50YQS)
    K160346 MX30N(MX30TQS)
    K160355 CX20N(CX20PUX)
    K160351 CX50N, CX50YQS