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

    Dell UP3216Q with QUBYX PerfectLum bundle

    K Number: K162196 · Decision Aug 15, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    134
    Applicant Total
    2
    Review Days
    10

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    Basic Information

    Device Name
    Dell UP3216Q with QUBYX PerfectLum bundle
    K Number
    K162196
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Qubyx Software Technologies, Inc.
    Date Received
    August 5, 2016
    Decision Date
    August 15, 2016
    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 Qubyx Software Technologies, Inc.

    K Number Device Name
    K171229 DELL UP3017 with QUBYX PerfectLum bundle