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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 Class Implantable

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Brainlab Elements Fibertracking - 04056481142186

No Description
Brainlab AG
2.0
In Commercial Distribution

  • 04056481142186 ()


  • Radiological PACS software
  • Stereotactic system application software

Brainlab Elements Image Fusion - 04056481140816

No Description
Brainlab AG
4.0
In Commercial Distribution

  • 04056481140816 ()


  • Radiological PACS software
  • Stereotactic system application software

Brainlab Elements Image Fusion Angio - 04056481138530

No Description
Brainlab AG
1.0
In Commercial Distribution

  • 04056481138530 ()


  • Radiological PACS software
  • Stereotactic system application software

Surgimap® - 00859699006059

The Surgimap® software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap® users. Clinical judgment and experience are required to properly use the software.
NEMARIS, INC
2.X
In Commercial Distribution

  • 00859699006059 ()


  • Patient health record information system
  • Radiological PACS software

Surgimap® - 00859699006042

The Surgimap® software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap® users. Clinical judgment and experience are required to properly use the software.
NEMARIS, INC
2.2.9.X
In Commercial Distribution

  • 00859699006042 ()


  • Radiological PACS software
  • Patient health record information system

PACSgear Core Server - 00850677007167

PACSgear Core Server
HYLAND LLC
4.X
In Commercial Distribution

  • 00850677007167 ()


  • Radiological PACS software
  • Medical image management system

interWORKS - 00850054590114

No Description
Avreo Inc
Version 8.7.0.21126
In Commercial Distribution

  • 00850054590114 ()


  • Radiological PACS software
  • Radiology information system

interWORKS - 00850054590091

No Description
Avreo Inc
Version 8.7.0.21082
In Commercial Distribution

  • 00850054590091 ()


  • Radiological PACS software
  • Radiology information system

interWORKS - 00850054590077

No Description
Avreo Inc
Version 8.6.0.20992
In Commercial Distribution

  • 00850054590077 ()


  • Radiological PACS software
  • Radiology information system

interWORKS - 00850054590121

No Description
Avreo Inc
Version 8.8.0.21349
In Commercial Distribution

  • 00850054590121 ()


  • Radiological PACS software
  • Radiology information system
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