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510(k) Data Aggregation

    K Number
    K182374
    Device Name
    LIAC S
    Date Cleared
    2019-05-22

    (264 days)

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

    Sit Sordina Iort Technologies Spa

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    LIAC S is mobile electron linear accelerator for intra-operative radiotherapy (IORT). Known as intraoperative radiation therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumours or other sites. The LIAC S is meant to be used for radiotherapy in the operating theatre on a patient to which the surgeon has just removed a neoplasm. The device must be sold by or on the order of a physician. The device is not for use by the general public or over-the-counter. LIAC S is an electron accelerator that can work in an operating theatre respecting its specific characteristics in terms of cleaning possibility, noise and heat dissipation; in particular, they do not require to move the patient.
    Device Description
    LIAC S is an electron linear Accelerator used to perform radiation therapy during surgical procedures in an operating room on a patient from whom the Surgeon has just removed a tumor. This technique is known as Intra-Operative Radiation Therapy (IORT) and it is used for the treatment of malignant and benign conditions. IORT allows delivering of high doses of radiation directly to turnour site, while normal tissues are protected against dosage impact. The available version of LIAC S is the 12 MeV one, with selectable energies of 6, 8, 10, 12 MeV and with electrical power requirement of 230 V, 50 Hz and 3kVA. LIAC S model employs the same technology as its predicate, LIAC HWL, with the following differences: 1. The Control Unit frame; 2. The total length of the applicator; 3. The design of the remote controller. All the differences have no impact on the product performances. The Equipment, LIAC S, is a system for Intraoperative Radiotherapy comprised of two main parts, Control and Mobile Unit, and the applicators. The main parts, connected by a ten meters-long cable which transfers the signals and the power are: 1) MOBILE UNIT (STAND). The Mobile Unit is a mobile component which emits the radiation. It is placed in the operating room near the patient with a remote-control device; 2) CONTROL UNIT. The Control Unit is a mobile component too. It is connected to the mobile unit through a group of cables. It is the part of the device that controls the equipment. Both the above listed components, the mobile unit (1) and the control unit (2), are joined by a cable of about 10 meters, to allow positioning the mobile unit in the operating theatre close to the patient, while the console control unit remains outside of the operating theatre allowing the operator to control the radiation. The equipment can perform its action only if the Mobile Unit and the Control Unit are connected adequately and the applicator is installed.
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    K Number
    K172961
    Device Name
    LIAC HWL
    Date Cleared
    2018-06-11

    (258 days)

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

    Sit Sordina Iort Technologies Spa

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    LIAC HWL are mobile electron linear accelerators for intra-operative radiotherapy (IORT). Known as intraoperative radiation therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumors or other sites. The LIAC HWL are meant to be used for radiotherapy in the operating theatre on a patient to which the surgeon has just removed a neoplasm. The devices must be sold by or on the order of a physician. They are not for use by the general public or over-the-counter. LIAC HWL are electron accelerators that can work in an operating theater respecting its specific characteristics in terms of cleaning possibility, noise and heat dissipation; in particular, they do not require to move the patient.
    Device Description
    LIAC HWL are mobile electron linear accelerators for intra-operative radiotherapy (IORT). The device consists of a STAND (irradiating unit), CONTROL UNIT, and APPLICATORS. It is a LINAC type structure with HARD DOCKING. It emits an ELECTRON BEAM.
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