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

    U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000

    K Number: K013902 · Decision Jun 5, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    6
    Review Days
    191

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    Basic Information

    Device Name
    U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000
    K Number
    K013902
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    U-Systems, Inc.
    Date Received
    November 26, 2001
    Decision Date
    June 5, 2002
    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 U-Systems, Inc.

    K Number Device Name
    K052355 AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
    K032640 FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM
    K022517 USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY
    K013848 U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000
    K003479 U-SYSTEMS ULTRASOUND SYSTEM USI-2000