LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K080555
    Device Name
    SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)
    Manufacturer
    IVU IMAGING CORPORATION
    Date Cleared
    2008-06-03

    (96 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVU IMAGING CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sofia™ (ATUS) device is indicated for use as a B-mode ultrasonic imaging system for imaging of a patient's breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography.
    Device Description
    The Sofia™ (ATUS) device consists of three (3) major components 1) an exam table which houses the examination pyramid, motor drive assembly, fluidics evacuation and storage system, and the power supply assembly 2) an ultrasound probe which is embedded into the exam pyramid on one end and connected to the ultrasound system on the other end, 3) an ultrasound system that acquires and stores the ultrasound data from the patient's breast exam.
    Ask a Question

    Page 1 of 1