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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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Quantib Brain - 08719689791254

No Description
Quantib B.V.
1.5
In Commercial Distribution

  • 08719689791254 ()


  • MRI system application software

Quantib ND - 08719689791216

No Description
Quantib B.V.
2.1
In Commercial Distribution

  • 08719689791216 ()


  • MRI system application software

Quantib ND - 08719689791179

No Description
Quantib B.V.
2.0
In Commercial Distribution

  • 08719689791179 ()


  • MRI system application software

Quantib ND - 08719689791148

No Description
Quantib B.V.
1.8
In Commercial Distribution

  • 08719689791148 ()


  • MRI system application software

Quantib ND - 08719689791094

No Description
Quantib B.V.
1.7
In Commercial Distribution

  • 08719689791094 ()


  • MRI system application software

Quantib Brain - 08719689791070

No Description
Quantib B.V.
1.4
In Commercial Distribution

  • 08719689791070 ()


  • MRI system application software

Quantib ND - 08719689791032

No Description
Quantib B.V.
1.6
In Commercial Distribution

  • 08719689791032 ()


  • MRI system application software

Quantib ND - 08719689791001

No Description
Quantib B.V.
1.5
In Commercial Distribution

  • 08719689791001 ()


  • MRI system application software

Segment CMR - 07350010100027

Software for cardiac image analysis.
Medviso AB
2
In Commercial Distribution

  • 07350010100027 ()


  • MRI system application software

SyMRI - 07340024700078

SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from supported MR sequences to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI is intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from SyMRI. SyMRI can also generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. When interpreted by a trained physician, output from SyMRI can provide information useful in determining diagnosis. SyMRI 2D is intended to be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR). T1W and T2W images from SyMRI 3D may replace conventional MR images in a clinical setting when interpreting together with a conventional 3D T2W FLAIR image.
SyntheticMR AB (publ)
15
In Commercial Distribution

  • 07340024700078 ()


  • MRI system application software
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