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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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FerriScan, Cardiac T2* - 09355529000002

Software tool to facilitate the import and visualization of multi slice, spin echo MRI data sets encompassing the liver and cardiac tissue, with functionality independent of the MRI equipment vendor. The operational principle is based on fitting signal decay curves to the image signal intensities at the different echo times for the MR data set on a voxel by voxel (3 D pixel) basis to determine transverse relaxation rate (R2) images, that may be further transformed by a defined calibration to provide a quantitative measure of liver iron concentrations in vivo and fitting signal decay curves to magnetic resonance image signal intensities acquired at different echo times on a voxel by voxel (3 D pixel) basis to determine the signal decay rate (R2*) and time (T2*) The obtained results can be used for the following purposes: 1. Supporting clinical diagnoses about the status of liver iron concentration and cardiac iron. 2. Supporting the subsequent clinical decision making processes. 3. Supporting the use in clinical research trials, directed at studying changes in liver iron concentration as a result of interventions. 4. It contains an image viewer for importing DICOM images, browsing through patient datasets, viewing images and performing region of interest analysis.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
4.0.0
In Commercial Distribution

  • 09355529000002 ()


  • MRI system application software

USB-STICK MAGELLAN PRO V7.4 - 09120052071351

This media contains V 7.4 of the following registered Medical Devices: (DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X), (DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)
Tecan Austria GmbH
30220141 00
In Commercial Distribution

  • 09120052071351 ()
  • 09120052071368 ()
  • 09120052071375 ()
  • 09120052071382 ()
  • 09120052071399 ()
  • 09120052071450 ()
  • 09120052071467 ()
30220141

  • Laboratory instrument/analyser application software IVD

USB-STICK MAGELLAN PRO V7.5 - 09120052071320

This Media contains V7.5 of the following registered Medical Devices: (DI)09120052070880 SOFTWARE MAGELLAN PRO V7.x, (DI)09120052070910 SOFTWARE MAGELLAN PRO TRACKER V7.x
Tecan Austria GmbH
30219868 00
In Commercial Distribution

  • 09120052071344 ()
  • 09120052071320 ()
  • 09120052071337 ()
  • 09120052071474 ()
  • 09120052071481 ()
  • 09120052071573 ()
30219868

  • Laboratory instrument/analyser application software IVD

USB-STICK MAGELLAN V 7.5 - 09120052071504

This media contains V 7.5 of the following registered Medical Devices: (DI)09120052070996 (SOFTWARE MAGELLAN V 7.X), (DI)09120052071009 (SOFTWARE MAGELLAN TRACKER V 7.X)
Tecan Austria GmbH
30231095 00
In Commercial Distribution

  • 09120052071504 ()
  • 09120052071511 ()
  • 09120052071528 ()
  • 09120052071535 ()
  • 09120052071542 ()
  • 09120052071559 ()
  • 09120052071566 ()
30231095

  • Laboratory instrument/analyser application software IVD

USB-STICK MAGELLAN V 7.5 SUNRISE+F50 - 09120052071238

This media contains V 7.5 of the following registered Medical Devices: (DI)09120052070996 (SOFTWARE MAGELLAN V 7.X), (DI)09120052071009 (SOFTWARE MAGELLAN TRACKER V 7.X)
Tecan Austria GmbH
30204301 00
Not in Commercial Distribution

  • 09120052071269 ()
  • 09120052071238 ()
  • 09120052071276 ()
  • 09120052071283 ()
  • 09120052071290 ()
  • 09120052071306 ()
  • 09120052071313 ()
  • 09120052071412 ()
  • 09120052071429 ()
  • 09120052071436 ()
  • 09120052071443 ()
30204301

  • Laboratory instrument/analyser application software IVD

USB-STICK MAGELLAN PRO V7.4 - 09120052071092

This media contains V 7.4 of the following registered Medical Devices: (DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X), (DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)
Tecan Austria GmbH
30185384 00
Not in Commercial Distribution

  • 09120052071108 ()
  • 09120052071092 ()
  • 09120052071115 ()
  • 09120052071122 ()
  • 09120052071139 ()
30185384

  • Laboratory instrument/analyser application software IVD

USB-STICK MAGELLAN 7.3 SP2 - 09120052071023

This media contains the following registered Medical Devices: (DI) 09120052070996 MAGELLAN V7.X (DI) 09120052071009 MAGELLAN TRACKER V7.X
Tecan Austria GmbH
30182624 00
In Commercial Distribution

  • 09120052071023 ()
  • 09120052071030 ()
  • 09120052071047 ()
  • 09120052071054 ()
  • 09120052071061 ()
  • 09120052071078 ()
  • 09120052071085 ()
30182624

  • Laboratory instrument/analyser application software IVD

MAGELLAN - 09120052071009

Reader control and data reduction software for Tecan Microplate Reader.
Tecan Austria GmbH
MAGELLAN TRACKER V7.X
In Commercial Distribution

  • 09120052071009 ()
30183890

  • Laboratory instrument/analyser application software IVD

MAGELLAN - 09120052070996

Reader control and data reduction software for Tecan Microplate Reader.
Tecan Austria GmbH
MAGELLAN V7.X
In Commercial Distribution

  • 09120052070996 ()
30183889

  • Laboratory instrument/analyser application software IVD

USB-STICK MAGELLAN PRO V 7.3 - 09120052070941

This media contains V 7.3 of the following registered Medical Devices: (DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X), (DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)
Tecan Austria GmbH
30141795 00
Not in Commercial Distribution

  • 09120052070934 ()
  • 09120052070941 ()
  • 09120052070927 ()
  • 09120052070972 ()
  • 09120052070965 ()
30141795

  • Laboratory instrument/analyser application software IVD
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