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

    AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS

    K Number: K052355 · Decision Sep 14, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    6
    Review Days
    16

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    Basic Information

    Device Name
    AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
    K Number
    K052355
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    U-Systems, Inc.
    Date Received
    August 29, 2005
    Decision Date
    September 14, 2005
    Product Code
    IYO
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IYO System, Imaging, Pulsed Echo, Ultrasonic

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    Other Clearances by U-Systems, Inc.

    K Number Device Name
    K032640 FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM
    K022517 USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY
    K013902 U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000
    K013848 U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000
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