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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?
    Applicant Name (Manufacturer) :

    GAMMEX, INC.

    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
    K954564
    Device Name
    PID-1 PRECISION INTELLIGENT DOSIMETER
    Manufacturer
    GAMMEX, INC.
    Date Cleared
    1996-04-22

    (203 days)

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

    GAMMEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used for precision measurement of ionizing radiation beams.
    Device Description
    The PID-1 Precision Intelligent Dosimeter is a battery-powered, stand-alone, precision electrometer for the calibration of medical radiation beams. It is designed to accommodate different types of ionization chambers and solid state detectors. The PID-1 also incorporates features for logging and transferring measured data to a host computer for analysis. The PID-1 measures charge, charge rate (current), dose and dose rate. Time and date of measurement are automatically stored with the data. Temperature and pressure data can be entered for automatic correction of measurements.
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