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510(k) Data Aggregation
K Number
K152303Device Name
CT Sim Laser System
Manufacturer
GAMMEX, INC.
Date Cleared
2015-09-11
(28 days)
Product Code
IWE
Regulation Number
892.5780Why 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
K973162Device Name
DUAL RADIATION TARGETING SYSTEM DRTS DRAPE
Manufacturer
HOGAN & HARTSON
Date Cleared
1997-11-20
(90 days)
Product Code
IWE
Regulation Number
892.5780Why 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
K955236Device Name
GREEN TEC-2100
Manufacturer
MEDTEC, INC.
Date Cleared
1996-05-24
(192 days)
Product Code
IWE
Regulation Number
892.5780Why did this record match?
Product Code :
IWE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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