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

    C-QUEST

    K Number: K082581 · Decision Nov 14, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    8
    Review Days
    70

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    Basic Information

    Device Name
    C-QUEST
    K Number
    K082581
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medx, Inc.
    Date Received
    September 5, 2008
    Decision Date
    November 14, 2008
    Product Code
    KPS
    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
    KPS System, Tomography, Computed, Emission

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    Other Clearances by Medx, Inc.

    K Number Device Name
    K073456 T-QUEST SYSTEM
    K041840 MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM
    K012953 GIOTTO IMAGE
    K993893 MEDX INTECAM INTERFACE
    K884661 D-SCOPE III
    K872127 D-SCOPE II AND D-SCOPE IIC
    K870703 SKAN D-SCOPE