Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K990052
    Device Name
    TEL-ECHO SYSTEM
    Date Cleared
    1999-02-19

    (43 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVATIVE MEDICAL SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Tel-Echo System is intended to acquire echocardiographic images during a cardiac ultrasound exam and transfer them to another location for viewing. This system is intended for tele-echocardiography applications.
    Device Description
    The Tel-Echo System is designed specifically to transmit cardiac ultrasound (echocardiographic) exams over telephone lines for remote review. This application is usually referred to as tele-echocardiography. A Tel-Echo System may send complete exams from a remote clinic to the main clinic. It may also send selected images to a physician's home or office for "on call" coverage. The Tel-Echo System acquires echocardiographic images in parallel with the VCR(Video Cassette Recorder) or other recording method. This VCR tape or equivalent digital media comprise the exam record and not the Tel-Echo system, which is for communication only.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1