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510(k) Data Aggregation

    K Number
    K022858
    Device Name
    SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
    Manufacturer
    NOVASONICS, INC.
    Date Cleared
    2002-09-06

    (9 days)

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

    NOVASONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use by a qualified physician for ultrasound evaluation of Fetal: Abdominal: Intra-operative (abdominal, thoracic, and vascular); Intra-operative Neuro; Pediatric; Small Organ (Thyroid, Breast, Testes, etc.); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans vaginal; Trans-esoph. (non-cardiac); Cardiac Adult; Cardiac Pediatric; Trans-esoph (Cardiac), Peripheral Vessel.
    Device Description
    The SuperNova is a general purpose diagnostic ultrasound system. It consists of a Personal Display Unit approximately 4 inches wide and 3 inches high that can be held by the user in one hand and includes buttons for controlling the system and a screen that display ultrasound mages and user interface . The Imaging Unit can be held by the user in one hand accommodates a removable transducer module. Signals received from the transducer module are digitized and preprocessed. The transducer module comes into contact with the patient and both transmits and receives ultrasound energy. The docking station provides holders for the Personal Display Unit, the Imaging Unit, and transducer modules, as well as battery chargers.
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