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510(k) Data Aggregation

    K Number
    K241051
    Device Name
    Vave Wireless Ultrasound System
    Manufacturer
    Date Cleared
    2024-08-30

    (135 days)

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

    Vave Health, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vave Wireless Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. The Vave Wireless Ultrasound System is intended to be used by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training. The Vave Wireless Ultrasound System is a transportable system that is intended for use in environments where healthcare is provided by trained healthcare professionals (e.g., Hospital, clinic, medical office), home environment, roadlair ambulance and other environments where is provided. The Vave Charger is to be used in a stationary setting. It is indicated for diagnostic ultrasound imaging in the following applications: Ophthalmic, Fetall Obstetrics, Abdominal (includes Gynecology, Renal, and Urology), Pediatric, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Small Organ (includes Breast, Thyroid, and Scrotum), Thoracic/Pleural, Cardiac Adult, Cardiac Pediatric, Peripheral Vessel and procedural guidance of needles into the body. The operating modes are B mode, M mode, B+M, B+C, CD mode.
    Device Description
    The Vave Wireless Ultrasound System is a handheld ultrasound imaging system consisting of the following components: Ultrasound Probe, Display Application, Battery, and Batterv Charger. The ultrasound probe (Model VA-0192), including its embedded software, is designed to acquire ultrasound image data and to wirelessly transmit the data to the display application software. The display application software runs on a commercial off-the-shelf mobile device. The operating system of the mobile device can be either iOS or Android. The ultrasound probe is completely wireless and is powered by a removable Li-ion battery (Model VA-0175). The battery is charged with a proprietary charging system (Model VCG).
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    K Number
    K191541
    Device Name
    Vave Personal Ultrasound System
    Manufacturer
    Date Cleared
    2019-07-10

    (29 days)

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

    Vave Health, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vave Personal Ultrasound is intended for diagnostic ultrasound imaging in B-Mode. It is indicated for diagnostic ultrasound imaging in the following applications: Fetal/Obstetric, Abdominal (includes Gynecology, Renal, and Urology), Pediatric, Thoracic/Pleural, Cardiac Pediatric, Peripheral Vessel and procedural guidance of needles into the body. The Vave Personal Ultrasound is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.
    Device Description
    The Vave Personal Ultrasound is a handheld ultrasound imaging system consisting of the following components: Ultrasound Probe, Display Application, Battery Charger. The ultrasound probe, including its embedded software, is designed to acquire ultrasound image data and to wirelessly transmit the data to the display application software. The display application software runs on a commercial off-the-shelf mobile device. The operating system of the mobile device can be either iOS or Android. The ultrasound probe is completely wireless and is powered by a removable Li-ion battery is charged with a proprietary charging system. The Vave Personal Ultrasound is intended for use in environments where healthcare is provided by healthcare professionals, including home healthcare environments and emergency medical services, ambulance, or aircraft environments.
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