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

    GE LOGIQ 9 MODEL 2375600

    K Number: K030934 · Decision Apr 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    54
    Review Days
    23

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    Basic Information

    Device Name
    GE LOGIQ 9 MODEL 2375600
    K Number
    K030934
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Medical Systems, Inc.
    Date Received
    March 25, 2003
    Decision Date
    April 17, 2003
    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 Ge Medical Systems, Inc.

    K Number Device Name
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    K042053 INNOVA 4100, INNOVA 3100
    K040125 SENOGRAPHIC STEREO
    K033244 DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
    K031209 GE 1.5T 8 CHANNEL TORSO COIL
    K023943 CT COLONOGRAPHY
    K030953 GE 3.0T GENERAL PURPOSE FLEX COIL
    K030495 3.0T TORSO PHASED ARRAY COIL
    Search all 54 clearances from Ge Medical Systems, Inc. →