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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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QLAB Advanced Quantification Software - 00884838122277

VM11.0 update
Philips Ultrasound LLC
795041
In Commercial Distribution

  • 00884838122277 ()


  • Radiological PACS software

QLAB Advanced Quantification Software - 00884838115323

No Description
Philips Ultrasound LLC
Release 15.6
In Commercial Distribution

  • 00884838115323 ()
795041

  • Radiological PACS software

Qlab Quantification Software 13.0 - 00884838102903

No Description
Philips Ultrasound LLC
989605496482
In Commercial Distribution

  • 00884838102903 ()


  • Radiological PACS software

FUJIFILM - 04547410541199

This software is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. This software is used with standard White Light Imaging (WLI) and Linked Color Imaging (LCI) endoscopy imaging. This software is not intended to replace clinical decision making.
FUJIFILM CORPORATION
EW10-EC02
In Commercial Distribution

  • 04547410541199 ()


  • Endoscopic video image interpretive software

ColonPRO™ 4.0 - 08055060110376

No Description
LINKVERSE SRL
4.0.1-S
In Commercial Distribution

  • 78055060110375 ()
  • 08055060110376 ()
CPRO401S-US

  • Endoscopic video image interpretive software

ColonPRO™ 4.0 - 08055060110345

Software to be used in GI Genius™ systems.
LINKVERSE SRL
4.0.1
In Commercial Distribution

  • 78055060110344 ()
  • 08055060110345 ()
CPRO401-US

  • Endoscopic video image interpretive software

GI Genius™ Module 300 - 08055060110338

GI Genius™ system with software ColonPRO™.
LINKVERSE SRL
GGM300-US
In Commercial Distribution

  • 08055060110338 ()


  • Endoscopic video image interpretive unit

GI Genius™ Module 200 - 08055060110321

No Description
LINKVERSE SRL
GGM200.US
In Commercial Distribution

  • 08055060110321 ()


  • Endoscopic video image interpretive unit

GI Genius™ Module 100 - 08055060110314

No Description
LINKVERSE SRL
GGM100.US
In Commercial Distribution

  • 08055060110314 ()


  • Endoscopic video image interpretive unit

ColonPRO™ 4.0 - 08055060110291

No Description
LINKVERSE SRL
CPRO40.US
In Commercial Distribution

  • 78055060110290 ()
  • 08055060110291 ()


  • Endoscopic video image interpretive software
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