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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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When implemented together with CellaVision DM96 and software, the CellaVision Advanced RBC Application speeds up and simplifies the review process while delivering more standardized results. The application support RBC Differential by delivering a comprehensive pre-characterization based on 21 morphological characteristics
Cellavision AB
CAR-960099
In Commercial Distribution

  • 07350040973752 ()
CAR-960099

  • Laboratory instrument/analyser application software IVD
When implemented together with CellaVision DM1200 and software, the CellaVision Advanced RBC Application speeds up and simplifies the review process while delivering more standardized results. The application support RBC Differential by delivering a comprehensive pre-characterization based on 21 morphological characteristics
Cellavision AB
CAR-120099
In Commercial Distribution

  • 07350040973745 ()
CAR-120099

  • Laboratory instrument/analyser application software IVD
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-005099
Not in Commercial Distribution

  • 07350040973714 ()
CRRS-005099

  • Laboratory instrument/analyser application software IVD
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-005001
Not in Commercial Distribution

  • 07350040973707 ()
CRRS-005001

  • Laboratory instrument/analyser application software IVD
The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations.
Cellavision AB
CBF-960099
In Commercial Distribution

  • 07350040972564 ()
CBF-960099

  • Laboratory instrument/analyser application software IVD
The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations.
Cellavision AB
CBF-120099
In Commercial Distribution

  • 07350040972557 ()
CBF-120099

  • Laboratory instrument/analyser application software IVD
Phadia Prime
Phadia AB
12-4101-00
In Commercial Distribution

  • 07333066015101 ()
12-4101-00

  • Laboratory instrument/analyser application software IVD
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
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. When interpreted by a trained physician, the parametric maps, tissue maps, and volumetrics from SyMRI can provide information useful in determining diagnosis. SyMRI is indicated for head imaging. SyMRI can also generate multiple contrast weighted images from the parametric maps generated by post-processing data from M2D-MDME sequence. SyMRI enables post-acquisition image contrasts adjustments from acquisition using M2D-MDME sequence. When M2D-MDME acquisition data is used as input to SyMRI the synthetic contrast weighted images can also provide information useful in determining diagnosis. SyMRI is intended to be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
SyntheticMR AB (publ)
14
In Commercial Distribution

  • 07340024700061 ()


  • MRI system application software
SyMRI is a post-processing software medical device intended for use in visualization of the brain. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-delay, multi-echo acquisition (MDME) to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. SyMRI is also 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 MDME images. When interpreted by a trained physician, SyMRI images can provide information useful in determining diagnosis. SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
SyntheticMR AB (publ)
11
In Commercial Distribution

  • 07340024700030 ()


  • MRI system application software
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