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510(k) Data Aggregation

    K Number
    K112286
    Device Name
    NOVAC 11
    Manufacturer
    NEW RADIANT TECHNOLOGY S.P.A.
    Date Cleared
    2012-04-19

    (254 days)

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

    NEW RADIANT TECHNOLOGY S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NOVAC 11 is an electron linear accelerator used for radiation therapy during surgical procedures in an operating room for the treatment of malignant and benign conditions. Known 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.
    Device Description
    The device is a linear electron accelerator for intra-operative treatments. Thanks to its construction characteristics, it can be used directly in the operating room. NOVAC 11 is a reusable and non sterile electromedical device. It is a mobile and articulated device. It can be moved towards the patient and put in the needed positions to carry out the necessary radiotherapy. Radiation technique consists of administering a uniform and collimated dose of ionizing radiations to the tumor or other site. It is made through the surgical incision. Collimation is performed by "Applicators" made of PMMA to minimize braking radiation. Applicators are positioned according to the "Hard Docking" technique which ensures the maximum alignment accuracy, thus ensuring highly reproducible dosages. The accelerator is equipped with an uninterruptible power supply which makes it completely independent during the radiation phase. Indeed, it ensures radiation continuity even if there are network power interruptions.
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