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

    DIASONICS SMALL PARTS SCANNER

    K Number: K802979 · Decision Jan 22, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    42
    Review Days
    62

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    Basic Information

    Device Name
    DIASONICS SMALL PARTS SCANNER
    K Number
    K802979
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Diasonics, Inc.
    Date Received
    November 21, 1980
    Decision Date
    January 22, 1981
    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 Diasonics, Inc.

    K Number Device Name
    K962662 VINGMED SOUND COLOR FLOW MAPPING SYSTEM
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    K911435 CPA/3.5 MHZ PROBE
    K905200 SACA, 3.5 MHZ PROBE
    K903562 CW DOPPLER 2.25 MHZ PROBE
    K903984 CW DOPPLER/4.5 MHZ
    K896637 ACCESS(TM), SOFTWARE RELEASE 4.11P
    K893518 MT/S SOFTWARE RELEASE 5.0.
    K894290 ACCESS TM
    K893881 ACCESS TM
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