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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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Synergy ODM - 00850003069081

Synergy ODM 4.09.500 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.
4.09.500
Not in Commercial Distribution

  • 00850003069081 ()


  • Camera application software

IMAGEnet 6 - 00850003069074

The IMAGEnet 6 ver. 2.1.0 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.
2.1.0
In Commercial Distribution

  • 00850003069074 ()


  • Camera application software

IMAGEnet 6 - 00850003069050

The IMAGEnet 6 ver. 2.0.3 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.
2.0.3
In Commercial Distribution

  • 00850003069050 ()


  • Camera application software

Harmony - 00850003069043

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 - 00850003069036

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

IMAGEnet 6 - 00850003069029

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 - 00850003069012

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

IMAGEnet 6 - 00850003069005

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

Biovitals Analytics Engine - 08885018690021

No Description
BIOFOURMIS SINGAPORE PTE. LTD.
2.0
In Commercial Distribution

  • 08885018690021 ()


  • Physiologic monitor-installed software

Quicktome - 09358140000048

No Description
Omniscient Neurotechnology Pty Ltd (o8t)
1.3
In Commercial Distribution

  • 09358140000048 ()
SCI0001

  • Radiological PACS software
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