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 Class Implantable

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VISIOMED GROUP
BW-HR1
In Commercial Distribution

  • 03760165449270 ()


  • Cardiac mapping system
Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL2ENR0
In Commercial Distribution

  • 08714729994077 ()


  • Cardiac mapping system
Ablation Connection Box (SmartAblate)
BOSTON SCIENTIFIC CORPORATION
M004RA64030
In Commercial Distribution

  • 08714729986003 ()


  • Cardiac mapping system
Ablation Connection Box (IBI/Ampere)
BOSTON SCIENTIFIC CORPORATION
M004RA61030
In Commercial Distribution

  • 08714729985983 ()


  • Cardiac mapping system
Ablation Connection Box (Maestro™)
BOSTON SCIENTIFIC CORPORATION
M004RA6201US0
In Commercial Distribution

  • 08714729966326 ()


  • Cardiac mapping system
MAPPING SYSTEM CIT200 US
MEDTRONIC, INC.
CIT200
In Commercial Distribution

  • 00763000118280 ()


  • Cardiac mapping system
CART AFR-00013 SYSTEM US
MEDTRONIC, INC.
AFR-00013
In Commercial Distribution

  • 00763000871987 ()


  • Cardiac mapping system
MAPPING SYSTEM AFR-00003 US
MEDTRONIC, INC.
AFR-00003
In Commercial Distribution

  • 00763000871956 ()


  • Cardiac mapping system
RecordConnect Module Recording System Connector
ST. JUDE MEDICAL, INC.
H421088
In Commercial Distribution

  • 05414734210881 ()
H421088

  • Electrical-only medical device connection cable, reusable
  • Cardiac mapping system
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
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