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510(k) Data Aggregation

    K Number
    K152303
    Device Name
    CT Sim Laser System
    Manufacturer
    GAMMEX, INC.
    Date Cleared
    2015-09-11

    (28 days)

    Product Code
    IWE
    Regulation Number
    892.5780
    Why did this record match?
    Product Code :

    IWE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CT Sim Laser System is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the isocenter in the CT suite. The Gammex CT Sim is intended to read laser positioning coordinates in a Gammex specified software format from a file in a shared folder. Typically the coordinates were calculated by a Radiation Therapy Treatment Planning System (RTPS) using CT images and sent to the Hospital Information System (HIS), Oncology System (OIS) or other system, by the RTPS.
    Device Description
    The CT Sim Laser System allows the radiation oncologist, medical physicist and oncology technician to precisely mark a patient for radiation therapy. CT Sim provides the ability to move the lasers to particular coordinates for alignment/marking purposes on the patient. The coordinates that the lasers are to move to may be manually input through the software graphical user interface (GUI) or through a data file with a specific format (or DICOM). CT Sim is in no way integrated with the third party Radiation Therapy Treatment Planning System (RTPS) or imaging/radiological device. The primary technological characteristics of the CT Sim Laser System is usage of movable lasers, a handheld keypad, a power/control box, and a PC controller, which are operated by the CT Sim software to indicate isocenter in the CT suite.
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    K Number
    K973162
    Device Name
    DUAL RADIATION TARGETING SYSTEM DRTS DRAPE
    Manufacturer
    HOGAN & HARTSON
    Date Cleared
    1997-11-20

    (90 days)

    Product Code
    IWE
    Regulation Number
    892.5780
    Why did this record match?
    Product Code :

    IWE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DRTS™ Drape is intended to help prevent contamination of the DRTS™ device when used in the operating room or other surgical environment. The DRTS™ Drape is to be used in an operating room environment to cover the DRTS™ device when it is mounted on an x-ray machine for procedures wherein it is deemed desirable to protect the DRTS™ device from contamination with patient fluids or tissues.
    Device Description
    The DRTS™ Drape is a sterile plastic bag to cover the DRTS™ Dual Radiation Targeting System. The drape contains an optically flat clear window that will allow undistorted transmission of the laser beam from the DRTS™ to the patient.
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    K Number
    K955236
    Device Name
    GREEN TEC-2100
    Manufacturer
    MEDTEC, INC.
    Date Cleared
    1996-05-24

    (192 days)

    Product Code
    IWE
    Regulation Number
    892.5780
    Why did this record match?
    Product Code :

    IWE

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