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510(k) Data Aggregation

    K Number
    K243479
    Device Name
    EchoGuide (Version 1)
    Manufacturer
    Sonavex, Inc.
    Date Cleared
    2025-04-23

    (166 days)

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

    Sonavex, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EchoGuide is a vascular ultrasound imaging device meant to aid in identification of the cannulation site on the skin of mature arteriovenous fistulas/grafts (AVFs/AVGs) in adult patients by appropriately trained healthcare providers in clinical settings. This device is not meant to replace the current standard of care cannulation methods.
    Device Description
    EchoGuide is a 3D automated ultrasound solution designed to provide the benefits of ultrasound for arteriovenous fistula/graft cannulation without the need for extensive training. EchoGuide uses a three-dimensional probe to acquire live coronal plane images, in addition to automating imaging settings, to allow users to quickly assess the position, trajectory, and size of an arteriovenous fistula/graft. Users can then mark the position and trajectory of the access on the patient's skin before removing the probe and proceeding with cannulation. The EchoGuide probe houses a 2D array on a track. The piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed. The transducer is a 52 mm linear (192 element) motorized probe capable of capturing a volume of data. The motorized probe collects a series of 2D images to capture a volume. Through image analysis and processing, the volumes are sliced to create live coronal plane renderings. The ultrasound system has a laptop form factor, with a bottom touch screen for user interaction and an additional top screen for display. The ultrasound system includes a transmitter and receiver, are all self-contained within the case. The ultrasound system interfaces with the probe through a port on the right side of the system. The EchoGuide user interface defaults to a conventional 2D ultrasound image when the system powers on. Users can switch between this view, and the live coronal imaging via controls on the bottom screen of the ultrasound. Users can freeze the imaging and capture a snapshot of the fistula/graft as well. The snapshot displays a static view of the fistula/graft in the coronal and transverse planes. EchoGuide is intended to be used in a clinical setting at the point of hemodialysis care.
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    K Number
    K190039
    Device Name
    EchoSure Diagnostic Ultrasound System
    Manufacturer
    Sonavex, Inc
    Date Cleared
    2019-03-08

    (59 days)

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

    Sonavex, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EchoSure diagnostic ultrasound system and its transducer are in clinical examinations of blood vessels that are marked with an EchoMark LP implant. The system provides measurements and information about blood flow. The system is intended for use by trained medical health care professionals in support of clinical diagnosis.
    Device Description
    EchoSure is a portable diagnostic ultrasound system which applies the latest technologies to produce optimal images and provide information about blood flow in vessels. Various image parameter adjustments, dual high-resolution displays, and a custom probe are configured to provide clear and stable images. The system operates in B-Mode and Color Flow Doppler Mode. EchoSure is comprised of the EchoSure Ultrasound, the EchoSure Application, and the EchoSure Probe.
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    K Number
    K180621
    Device Name
    EchoMark, EchoMark LP
    Manufacturer
    Sonavex, Inc.
    Date Cleared
    2018-06-06

    (89 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sonavex, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EchoMark and EchoMark LP are indicated for radiographic marking of sites in soft tissue. In addition, the EchoMark LP are indicated for situations where a soft tissue site needs to be marked for future medical procedures.
    Device Description
    The EchoMark and EchoMark LP are implantable ultrasound-visible markers used to facilitate visualization of a soft tissue site. The EchoMark and EchoMark LP are comprised of 70:30 poly(L-lactide-co-caprolactone) (PLC) which resorbs completely in one year or more. The EchoMark LP (low profile) is identical but smaller in size than the EchoMark. Both have identical performance and technological characteristics. The EchoMark and EchoMark LP are provided sterile and are single use devices. The EchoMark material is entirely polymeric and therefore has no clinically relevant diamagnetic or ferromagnetic potential. This device is MR safe.
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