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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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No Description
Brainreader ApS
2.6
In Commercial Distribution



  • Image segmentation application software
No Description
Brainreader ApS
2.5
Not in Commercial Distribution



  • Image segmentation application software
No Description
Brainreader ApS
2.4
Not in Commercial Distribution



  • Image segmentation application software
No Description
Brainreader ApS
2.3
Not in Commercial Distribution



  • Image segmentation application software
No Description
Brainreader ApS
2.2.9
Not in Commercial Distribution



  • Image segmentation application software
No Description
Brainreader ApS
2.2.8
Not in Commercial Distribution

  • 05700002060402 ()


  • Image segmentation application software
neuroinspire is a stereotactic software application intended to allow trained clinicians to plan surgical trajectories for neurological procedures.
RENISHAW P L C
A-5630-3008
In Commercial Distribution

  • 05057078000024 ()
  • 15057078000021 ()


  • Image segmentation application software
AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Aeye Health, Inc.
AEYE-DS
In Commercial Distribution



  • Retinal image analysis software
AEYE-DS-Epic is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS-Epic is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR) and is integrated with the Epic EMR.
Aeye Health, Inc.
AEYE-DS-Epic
Not in Commercial Distribution

  • 00850035651018 ()


  • Retinal image analysis software
AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Aeye Health, Inc.
AEYE-DS
Not in Commercial Distribution

  • 00850035651001 ()


  • Retinal image analysis software
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