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510(k) Data Aggregation

    K Number
    K192170
    Device Name
    VistaScan USB Ultrasound Imaging System
    Date Cleared
    2020-01-23

    (164 days)

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

    Emagine Solutions Technology, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VistaScan™ USB Ultrasound Imaging System is intended for diagnostic ultrasound imaging in B mode for the following applications: Fetal/obstetric Gynecology Abdominal Pediatric Small organ Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Pelvic floor Neuro-muscular Peripheral vessel Indications for use vary by probe type. The VistaScan™ USB Ultrasound Imaging System is indicated for Rx (prescription) use and intended for use by appropriately trained healthcare professionals such as physicians and ultrasound technologists. The VistaScan™ USB Ultrasound Imaging System is intended for use in healthcare facilities such as hospitals, clinics and facilities where ultrasound testing is performed.
    Device Description
    The VistaScan™ USB Ultrasound Imaging System is a self-contained portable single-mode and multiple-application ultrasound imaging system. The system comprises a series of handheld probes containing an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface, and software-based controls offering B operating mode, parameter controls, and recording functions. The selection of transducers offered with the system permit a wide range of clinical applications including Fetal/Obstetric, Abdominal, Pediatric, Small Organ, Muscular-skeletal, Urology, Gynecology, Pelvic Floor, Neuromuscular, and Peripheral Vessel. The initial operational settings for each transducer are preprogrammed in the system. User-customized parameter settings for each transducer may be set by the operator within a specific range which is controlled by the transducer hardwareffirmware and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the Cine function. The VistaScan™ USB Ultrasound Imaging System is a B-Mode scanner and supports a wide variety of applications. It is an ultrasound scanner providing high resolution and high penetration performance. Probes are supported in frequencies from 2.5 MHz to 10.0 MHz. The product family uses non-array, curved, and flat linear array transducers and includes two General Purpose (GP) probes and a Small Parts (SP) probe. The probes can be connected to a USB 2.0 port (micro USB and USB-C). System Components: - Android™ based device operating VistaScan™ application . - Transducer GP-3.5 ● - Transducer GP-C01 ● - . Transducer SP-L01
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