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510(k) Data Aggregation

    K Number
    K990209
    Device Name
    NOVAC7
    Manufacturer
    HITESYS S.P.A.
    Date Cleared
    2000-06-22

    (518 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    HITESYS S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NOVAC7 is an electron linear accelerator used for radiation therapy during surgical procedures in an operating room for the treatment of malignant and benign conditions. Know as intraoperative radiation therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumors or other sites while avoiding dosage to surgically mobilized normal tissues. The NOVAC7 is a mobile and articulated machine that can be moved towards the patient and put in the appropriate position to carry out the necessary radiotherapy. Applicators direct the electron beam to the surgical area of interest.
    Device Description
    The NOVAC7 is an electron accelerator for intraoperative radiation therapy that can be used in the operating room without making major adjustments to the room. Beam energies are 3, 5, 7, and 9 MeV. It is a mobile, hinged accelerator that can be moved to the patient's location and placed in the appropriate position for performing the required radiotherapy inside a surgical theatre. X-ray leakage into the environment and other related radiation protection problems have been minimized by eliminating diffusion filters which in conventional accelerators widen the beam. Hard docking is performed in an easy way, reaching any site of the body. Two applicators are used, one is located over the patient area to be treated and the other is permanently mounted on the radiating head. Only the patient applicator comes in contact with the surgery site. The time required for performing docking and scanning irradiation is under five minutes.
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