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

    QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL.

    K Number: K890998 · Decision May 2, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    5
    Review Days
    88

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    Basic Information

    Device Name
    QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL.
    K Number
    K890998
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Quantum Medical Systems, Inc.
    Date Received
    February 3, 1989
    Decision Date
    May 2, 1989
    Product Code
    IYN
    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
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

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    Other Clearances by Quantum Medical Systems, Inc.

    K Number Device Name
    K904019 QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM
    K894992 QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM
    K860581 QAD-1 ANGIODYNOGRAPH ULTRASOUND SYSTEM
    K853217 QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES