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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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StrokeViewer LVO Triaging - 08720299502338

StrokeViewer LVO Triaging is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation.
NICo-Lab B.V.
3
In Commercial Distribution

  • 08720299502338 ()


  • X-ray image interpretive software

Lunit INSIGHT CXR Triage - 08800076000179

Lunit INSIGHT CXR Triage - Windows version
Lunit Inc.
1.0
In Commercial Distribution

  • 08800076000179 ()


  • X-ray image interpretive software

Lunit INSIGHT DBT - 08800076000162

No Description
Lunit Inc.
1.1
In Commercial Distribution

  • 08800076000162 ()


  • X-ray image interpretive software

Lunit INSIGHT DBT - 08800076000148

No Description
Lunit Inc.
1.0
In Commercial Distribution

  • 08800076000148 ()


  • X-ray image interpretive software

Lunit INSIGHT CXR Triage - 08800076000124

Linux version
Lunit Inc.
1.0
In Commercial Distribution

  • 08800076000124 ()


  • X-ray image interpretive software

Lunit INSIGHT MMG - 08800076000056

No Description
Lunit Inc.
1.1
In Commercial Distribution

  • 08800076000056 ()


  • X-ray image interpretive software

Rayvolve - 03770018071084

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult and pediatric population (2 years and over).
AZMED
4
In Commercial Distribution

  • 03770018071084 ()


  • X-ray image interpretive software

Rayvolve - 03770018071077

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult and pediatric population (2 years and over). (Variant : Full Cloud)
AZMED
4
In Commercial Distribution

  • 03770018071077 ()


  • X-ray image interpretive software

Rayvolve - 03770018071060

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult and pediatric population (2 years and over). (Variant : VM + Cloud)
AZMED
4
In Commercial Distribution

  • 03770018071060 ()


  • X-ray image interpretive software

Rayvolve - 03770018071022

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only. Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. (Variant : Cloud/VM)
AZMED
2
In Commercial Distribution

  • 03770018071022 ()


  • X-ray image interpretive software
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