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

    IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS.

    K Number: K813544 · Decision Feb 5, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    10
    Review Days
    46

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    Basic Information

    Device Name
    IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS.
    K Number
    K813544
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Irex Corp.
    Date Received
    December 21, 1981
    Decision Date
    February 5, 1982
    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 Irex Corp.

    K Number Device Name
    K844404 IREX PS, PORTABLE SCANNER AND 118
    K843643 COLOR DOPPLER 880
    K842408 IREX 730 MECHANICAL SECTOR SCANNER
    K840139 IREX 720 SECTOR SCANNER
    K827370 IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM
    K811246 DOPPLER ULTRASOUND BLOOD FLOWMETER
    K792525 IREX CARDIOPLAN
    K791317 IREX REAL TIME PHASED ARRAY SYSTEM
    K771372 SYSTEM II