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510(k) Data Aggregation

    K Number
    K973556
    Device Name
    IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000
    Manufacturer
    IMEX MEDICAL SYSTEMS, INC.
    Date Cleared
    1998-04-24

    (217 days)

    Product Code
    IYN
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMEX MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMEXLAB 9000 is a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases. Instrument is used in a vascular laboratory, clinic or hospital. It for use by or on order of a physician. It is not indicated for use near non-intact skin or the eyes. It is not intended for home use.
    Device Description
    Not Found
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    K Number
    K973562
    Device Name
    IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100
    Manufacturer
    IMEX MEDICAL SYSTEMS, INC.
    Date Cleared
    1998-04-15

    (208 days)

    Product Code
    IYN
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMEX MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMEXLAB 9100 is a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases. Instrument is used in a vascular laboratory, clinic or hospital. It for use by or on order of a physician. It is not indicated for use near non-intact skin or the eyes. It is not intended for home use.
    Device Description
    IMEXLAB 9100 Diagnostic Ultrasound Device
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    K Number
    K973336
    Device Name
    IMEX STETHODOP
    Manufacturer
    IMEX MEDICAL SYSTEMS, INC.
    Date Cleared
    1998-02-05

    (154 days)

    Product Code
    JAF
    Regulation Number
    892.1540
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMEX MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
    Device Description
    IMEX StethoDop™ (Doppler Ultrasound Device)
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    K Number
    K970156
    Device Name
    IMEX FUTURALDOP PRO
    Manufacturer
    IMEX MEDICAL SYSTEMS, INC.
    Date Cleared
    1997-04-04

    (78 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMEX MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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