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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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qXR-CTR - 00850057636000

qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans. qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm. The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities.
QURE.AI TECHNOLOGIES PRIVATE LIMITED
1.0.0
In Commercial Distribution

  • 00850057636000 ()


  • Radiology DICOM image processing application software

VEA Align - 03663999000337

No Description
EOS IMAGING
2.1
In Commercial Distribution

  • 03663999000337 ()


  • Basic diagnostic x-ray system application software

VEA Align - 03663999000290

No Description
EOS IMAGING
1.0
Not in Commercial Distribution

  • 03663999000290 ()


  • Basic diagnostic x-ray system application 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

Footswitch - 08055060110185

No Description
LINKVERSE SRL
Accessory to GI Genius
In Commercial Distribution

  • 08055060110185 ()
FS01

  • Foot-switch, electrical
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