Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K153620
    Device Name
    Enovare Ultrasound System
    Date Cleared
    2016-05-05

    (139 days)

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

    OREON TECHNOLOGIES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Enovare system's ultrasound scanner connected with a probe enables real time diagnostic ultrasound imaging for Bmode, Tissue and Contrast Harmonic Imaging, PWD, Power Doppler and combined mode imaging. Signal Analysis and display. Guidance of biopsy and therapy needles, geometrical measurements and calculation of parameters. The system offers optional probes each type optimized to image structure and orientation of tissues during specific clinical applications. These include general Abdominal, Intraoperative, Cardiac, Neurosurgery, Transrectal, Small organs, Urological, Transvaginal, Musculoskeletal.
    Device Description
    The Enovare supports the following scanning modes and combinations thereof: B-mode (incl. Tissue Harmonic Imaging), PWD mode, CFM mode, Amplitude (Power) Doppler mode. The system consists of: - system cart - keyboard ● - ultrasound probe(s) ● - LCD monitor ● The system can perform simple geometric measurements and perform calculations in the vascular and urology areas.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1