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510(k) Data Aggregation

    K Number
    K040804
    Device Name
    .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR
    Manufacturer
    SOUTHEASTERN RADIATION PRODUCTS, INC.
    Date Cleared
    2004-04-28

    (30 days)

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

    SOUTHEASTERN RADIATION PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    .decimal tissue compensator/intensity modulator manufacturing service manufactures the solid filters for missing tissue and intensity modulation for external beam radiation therapy.
    Device Description
    .decimal tissue compensator / intensity modulator manufacturing service
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    K Number
    K023636
    Device Name
    BLOCKING TRAY
    Manufacturer
    SOUTHEASTERN RADIATION PRODUCTS, INC.
    Date Cleared
    2002-11-22

    (23 days)

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

    SOUTHEASTERN RADIATION PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for mounting blocks and/or compensators/modulators for insertion into a Linear Accelerator head.
    Device Description
    Blocking Trays are to be used as an accessory to a Linac. Custom blocks are mounted onto Blocking trays and slid into the Linac into their accessory holder thereby stenciling the radiation beam onto the patient. Compensators are also mounted on blocking trays and slid into the Linac changing the radiation beam fluence unique to a patient's anatomy.
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