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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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Local version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.6 (Local)
In Commercial Distribution

  • 00850005944102 ()
83-00056-000

  • Magnetic neural stimulation system
Local version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.5 (Local)
In Commercial Distribution

  • 00850005944096 ()
83-00056-000

  • Magnetic neural stimulation system
A software for personalizing and optimizing magnetic brain stimulation treatment.
Magnus Medical, Inc.
Magnus Cloud Software
In Commercial Distribution

  • 00860011072508 ()


  • Magnetic neural stimulation system
Combined local/cloud version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.7
In Commercial Distribution

  • 00850005944515 ()
83-00060-000

  • Magnetic neural stimulation system
Computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest.
Infervision US Inc
2.1.2.1
In Commercial Distribution

  • 00850003095004 ()


  • X-ray image interpretive software
  • Diagnostic x-ray digital imaging system workstation
No Description
Brainlab AG
2.1
In Commercial Distribution

  • 04056481146337 ()


  • Electromagnetic/optical surgical navigation device tracking system
MultiView™ is a software application that provides various image processing and measurement tools to facilitate the interpretation of breast MRI images and enable diagnosis.
Hologic, Inc.
MultiView
In Commercial Distribution

  • 15420045504684 ()
SFW-03541

  • Laboratory instrument/analyser application software IVD
A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging.
MIM SOFTWARE INC.
7.4.70
In Commercial Distribution

  • 00850009343321 ()


  • Radiological PACS software
Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.
MIM SOFTWARE INC.
1.3
In Commercial Distribution

  • 00850009343307 ()


  • Radiological PACS software
Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.
MIM SOFTWARE INC.
1.2
In Commercial Distribution

  • 00850009343291 ()


  • Radiological PACS software
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