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

    MEDX INTECAM INTERFACE

    K Number: K993893 · Decision Feb 10, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    8
    Review Days
    86

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    Basic Information

    Device Name
    MEDX INTECAM INTERFACE
    K Number
    K993893
    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
    November 16, 1999
    Decision Date
    February 10, 2000
    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
    K082581 C-QUEST
    K073456 T-QUEST SYSTEM
    K041840 MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM
    K012953 GIOTTO IMAGE
    K884661 D-SCOPE III
    K872127 D-SCOPE II AND D-SCOPE IIC
    K870703 SKAN D-SCOPE