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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The CT Sim+, 3-Arm, Green Laser 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 radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
SUN NUCLEAR CORP.
CT Sim+
In Commercial Distribution

  • B1363000G0 ()
805652

  • Laser patient positioning system
The CT Sim+, 3-Arm, Blue Laser 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 radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
SUN NUCLEAR CORP.
CT Sim+
In Commercial Distribution

  • B1363000B0 ()
805657

  • Laser patient positioning system
The CT Sim+, 1-Arm, Red Laser 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 radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
SUN NUCLEAR CORP.
CT Sim+
In Commercial Distribution

  • B1361000RRC0 ()
805757

  • Laser patient positioning system
The CT Sim+, 1-Arm, Red Laser 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 radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
SUN NUCLEAR CORP.
CT Sim+
In Commercial Distribution

  • B1361000R0 ()
805653

  • Laser patient positioning system
The CT Sim+, 1-Arm, Green Laser 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 radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
SUN NUCLEAR CORP.
CT Sim+
In Commercial Distribution

  • B1361000GRC0 ()
805758

  • Laser patient positioning system
The CT Sim+, 1-Arm, Green Laser 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 radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
SUN NUCLEAR CORP.
CT Sim+
In Commercial Distribution

  • B1361000G0 ()
805654

  • Laser patient positioning system
The CT Sim+, 1-Arm, Blue Laser 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 radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
SUN NUCLEAR CORP.
CT Sim+
In Commercial Distribution

  • B1361000BRC0 ()
805759

  • Laser patient positioning system
The CT Sim+, 1-Arm, Blue Laser 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 radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
SUN NUCLEAR CORP.
CT Sim+
In Commercial Distribution

  • B1361000B0 ()
805656

  • Laser patient positioning system
The Calibration body EM is used to calibrate a surgical endoscope which is tracked with Endoscope tracker EM. The location of the Calibration Body EM is referenced relative to the Endoscope tracker EM and allows Navigation Software NOVA AR to compute the optical parameters of the attached surgical endoscope. The Calibration body EM connects to the Hybrid Navigation Unit EM via an integrated cable. The Calibration body EM is provided non-sterile and is intended to be sterilized by the user. The Calibration body EM is reusable.
Scopis GmbH
1.0
In Commercial Distribution

  • B057U1038020 ()
U1 038 02

  • Electromagnetic surgical navigation device tracking system
The DELTA 3300 Defibrillator / Transcutaneous Pacemaker Analyzer is a precision instrument for testing defibrillators and external (Transcutaneous) Pacemakers. It combines the complete testing functions of a Defibrillator Tester, Transcutaneous Pacemaker Analyzer, and 12-Lead ECG / Arrhythmia Simulator into one compact, lightweight, and easy-to-use instrument. The Delta 3300 tests all Defibrillators including AEDs. It measures both monophasic and Bi-Phasic waveforms. It is compact, lightweight and easy to use. The test results can be saved in the internal memory and uploaded to the PC and printed using ProComPrint software (CD included with the unit).
NETECH CORPORATION
DELTA 3300
In Commercial Distribution

  • B3356600 ()
660

  • External defibrillator tester
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