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510(k) Data Aggregation

    K Number
    K192182
    Device Name
    C015
    Manufacturer
    Micronica SRL
    Date Cleared
    2020-01-17

    (158 days)

    Product Code
    OWB, JAA, LMC, OXO
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Micronica SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The C015 device is used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures on all patients except neonates (birth to one month), within the limits of the device. The device is to be used in healthcare facilities both inside and outside the operating room, in sterile as well as nonsterile environments, in a variety of procedures. - Applications: - Orthopedic - Neuro - Abdominal - Vascular - Thoracic - Cardiac The device is intended to be used and operated by adequately tramed, qualified, and authorized health care professionals such as physicians, surgeons, cardiologists, and radiographers, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device.
    Device Description
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