Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K230511
    Device Name
    K3900 Ultrasound Imaging System
    Manufacturer
    Date Cleared
    2023-10-25

    (243 days)

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

    MAUI Imaging

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The K3900 Ultrasound Imaging System is intended for use by a qualified healthcare personnel in environments where healthcare is provided for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); and Intraoperative (abdominal, thoracic and vascular).
    Device Description
    The K3900 Ultrasound Imaging System ("K3900") is a Track 3 general purpose ultrasound imaging system. The device generates and collects ultrasonic pulsed echo data via a transducer that is then digitized for further processing. The processing includes beamforming, image processing, and image optimization that then outputs an ultrasound image. This image may be displayed on a tablet or common displays through HDMI for general purpose radiological evaluation. The K3900 consists of an ultrasound transducer, a processing unit that manages the transducer and all data processing, and a tablet that provides the user interface to operate the device, view and analyze the ultrasound dataset, and manage patient study sessions.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1