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510(k) Data Aggregation

    K Number
    K983678
    Device Name
    ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE
    Manufacturer
    ELEKTA INSTRUMENTS, INC.
    Date Cleared
    1999-01-15

    (87 days)

    Product Code
    JAI
    Regulation Number
    892.5770
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELEKTA INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Precise™ Treatment Table is intended as a universal patient treatment support and positioning table for radiation therapy and simulation use. It is for use with existing Elekta Linear Accelerators and Simulators and adaptable to third party radiotherapy products.
    Device Description
    The Precise™ Treatment Table is an enhancement to the previously reported EOS RAM and Pedestal devices that have been cleared for commercial distribution. These devices have established and proven track records for safety. This enhancement offers improved directional accuracy and repeatability to provide for easier and more efficient patient set up. The Precise™ Treatment Table is further considered as an enhancement to the RAM and Pedestal devices.
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    K Number
    K955064
    Device Name
    SPETZLER TI 100 ANEURYSM CLIP
    Manufacturer
    ELEKTA INSTRUMENTS, INC.
    Date Cleared
    1996-10-17

    (346 days)

    Product Code
    HCH
    Regulation Number
    882.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELEKTA INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spetzler Ti 100 Aneurysm Clips are intended for: - . Temporary occlusion of intracranial blood vessels/aneurysms - Permanent placement in the brain for occlusion of intracranial aneurysms .
    Device Description
    Spetzler Ti 100 Aneurysm Clips are manufactured from titanium--Certified ASTM F67-89, "Unalloyed Titanium for Surgical Implant Applications, Grade IV" (see ASTM F67-89 specifications). This grade of titanium is often referred to as "Commercially Pure Titanium," or "C. P. Titanium." The basic models are distinguished by their surface finish: natural metallic color for clips intended for permanent implantation, and blue for temporary clips. Aneurysm Clips, whether those proposed by Elekta or those manufactured or distributed by the sponsors of the predicate devices, are available in a wide variety of styles and sizes in order that all of the sizes and shapes of aneurysms can be treated. The clips are available for both temporary and permanent placement in the brain. Spetzler Ti 100 Aneurysm Clips are applied with the Elekta Titanium Nitride Coated Clip Appliers to avoid foreign metal transfer. Clips are sterilized in the Elekta Sterilization Tray.
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    K Number
    K941823
    Device Name
    LEKSELL NEURO GENERATOR AND ACCESSORIES
    Manufacturer
    ELEKTA INSTRUMENTS, INC.
    Date Cleared
    1996-03-22

    (709 days)

    Product Code
    GXD
    Regulation Number
    882.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELEKTA INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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