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510(k) Data Aggregation

    K Number
    K062781
    Device Name
    MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY
    Manufacturer
    SYMTIUM CORPORATION
    Date Cleared
    2006-11-21

    (64 days)

    Product Code
    IXI
    Regulation Number
    892.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYMTIUM CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Symtium Corporation precision milled brass compensators are used for modulation of beam intensity during radiation therapy.
    Device Description
    The Symtium Corporation Mod1 Compensators for Radiation Beam Therapy are used for modulation of beam intensity during radiation therapy (IMRT). Initially, a plan for the compensator design is generated by the staff of the Cancer Center using treatment planning software such as Pinnacle, Eclipse, or CMS (and others). This compensator design file is then transferred to Symtum Corporation via secure online data transfer, and imported into their custom designed manufacturing software. Typically, a brass round is used as a basis for the compensator. It is placed into the milling machine and worked into precise X, Y and Z dimensions to match the treatment planning output. It is then removed from the milling machine and subjected to an extensive QA process to verify the accuracy of the process non the match between the physical dimensions of the compensator and the treatment planing outputs. The device is then mounted onto a carrier specific to the linear accelerator (LINAC) used for patient treatment. The finished device is then packaged and mailed to the Cancer Center via commercial package transport companies. Once received by the Cancer Center, the compensator is unpackaged and once again undergoes a QA process to confirm the accuracy of the manufacturing process in onec ugain andiation fluency map as well as radiation dose. At this point, the device is moved into the LINAC vault for patient freatient The compensator is then locked into place on the LINAC in the accessory collect During patient treatment, a photon beam is generated by the LINAC and directed toward the patient. The compensator attenuates the photon beam based upon the thickness and shape of the brass. In general, the device shields sensitive portions of the treatment, and may. Of the was. In of the radiation on the tumor. Brass is a heavy, dense material with the ability to "attenuate" or block the amount of radiation that passes through it. When the milled brass compensator is mounted in the accessory collar of the LINAC, the photon beam aimed at the patient is "attenuated" is the area according to the thickness of the brass. Thicker areas "attenuate" or block more photon bean than the thinner areas. Generally, the thinner areas of the compensator would correspond to the tumor, while the thicker areas would overly surrounding "normal" tissue. In this way the tumor receives a maximum, effective dose of radiation while surrounding areas receive little or no radiation, sparing them from damage and the patient from side effects of the treatment.
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