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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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Nordicneurolab AS
1.1
In Commercial Distribution

  • 07090042059046 ()


  • MRI system application software
NordicNeuroLab’s nordicAktiva is a stimulus presentation and workflow software which controls the presentation of stimuli during fMRI exams and has been designed specifically with the clinical user in mind. With an intuitive interface and detailed, easy-to-follow instructions, the user is guided step-by-step through the process of presenting stimuli during MR image acquisition. nordicAktiva runs on the stimulus presentation PC to which the NNL fMRI Hardware System is connected. Through the latter audiovisual stimuli are presented to, and feedback is collected from the patient.
Nordicneurolab AS
1.3
In Commercial Distribution

  • 07090042059022 ()


  • MRI system application software
The nordicBrainEx Software is a post-processing application for dynamic MRI data developed with focus on ease of use and high performance on a standard Windows workstation. The software provides comprehensive functionality for dynamic image analysis and visualization of MRI data, where signal changes over time are analyzed to determine various modality dependent functional parameters. The following algorithms provide the main functional analyses of the application. - BOLD: BOLD fMRI analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity. - DTI: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilizes the directional dependency of the diffusion to display the white matter structure in the brain. - DSC: Calculations of perfusion related parameters that provide information about the blood vessel structure and characteristics. Examples of such maps are blood volume, blood flow, time to peak, mean transit time and leakage. In addition to these specific functional analyses, the application also provides general visualization tools, a database for data handling, and a reporting feature. This is to ensure that the workflow of the application is optimized to ensure efficiency and high throughput in a clinical environment.
Nordicneurolab AS
2.3
In Commercial Distribution

  • 07090042059015 ()


  • MRI system application software
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For I-Phone 5/5S/SE
In Commercial Distribution

  • 07290012140983 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
The iQMR is a software package, connected to the clinic LAN, that receive and transfer MRI images. The image processing provide enhanced quality by reducing the image noise level.
MEDIC VISION - IMAGING SOLUTIONS LTD
1.2
In Commercial Distribution

  • 07290016836400 ()


  • MRI system application software
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
YO: Universal 3.0 packed kit for Quest Diagnostics - 3 tests
In Commercial Distribution

  • 07290016650792 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
YO: Universal 3.0 packed kit for Bird & Be - 3 tests
In Commercial Distribution

  • 07290016650785 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
YO: Universal 3.0 packed kit for PROOV - 3 tests
In Commercial Distribution

  • 07290016650778 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
YO 3.0: Refill Pack of 3 Tests
In Commercial Distribution

  • 07290016650761 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
YO 3.0
In Commercial Distribution

  • 07290016650754 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
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