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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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Harmony 5.04 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE SOLUTIONS, INC.
5.04
Not in Commercial Distribution

  • 00850003069043 ()


  • Camera application software
Synergy ODM 4.10.500 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE SOLUTIONS, INC.
4.10.500
Not in Commercial Distribution

  • 00850003069036 ()


  • Camera application software
The IMAGEnet 6 ver. 2.0.2 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.
TOPCON HEALTHCARE SOLUTIONS, INC.
2.0.2
In Commercial Distribution

  • 00850003069029 ()


  • Camera application software
Harmony 5.03 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE SOLUTIONS, INC.
5.03
In Commercial Distribution

  • 00850003069012 ()


  • Camera application software
The IMAGEnet 6 ver. 2.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.
TOPCON HEALTHCARE SOLUTIONS, INC.
2.0
In Commercial Distribution

  • 00850003069005 ()


  • Camera application software
No Description
BIOFOURMIS SINGAPORE PTE. LTD.
2.0
In Commercial Distribution

  • 08885018690021 ()


  • Physiologic monitor-installed software
No Description
Omniscient Neurotechnology Pty Ltd (o8t)
1.3
In Commercial Distribution

  • 09358140000048 ()
SCI0001

  • Radiological PACS software
No Description
Omniscient Neurotechnology Pty Ltd (o8t)
1.2
In Commercial Distribution

  • 09358140000024 ()
SCI0001

  • Radiological PACS software
No Description
Omniscient Neurotechnology Pty Ltd (o8t)
1.1
In Commercial Distribution

  • 09358140000017 ()
SCI0001

  • Radiological PACS software
ResScan V6.1 CD ASSY
RESMED PTY LTD
31336
In Commercial Distribution

  • 00619498313365 ()
31336

  • Ventilator application software
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