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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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Critical Care Suite - 00840682147231

Designated Medical Device, Critical Care Suite PACS 1.0
GE MEDICAL SYSTEMS, INC.
PACS 1.0
In Commercial Distribution

  • 00840682147231 ()


  • X-ray image interpretive software

Critical Care Suite - 00840682146340

No Description
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 00840682146340 ()


  • X-ray image interpretive software

MammoScreen - B885MAML2US0

Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAL2US
In Commercial Distribution

  • B885MAML2US0 ()


  • X-ray image interpretive software

MammoScreen - B885MAML0

Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAML
In Commercial Distribution

  • B885MAML0 ()
MAML

  • X-ray image interpretive software

SmartChest - 03770024774016

No Description
MILVUE
V2.x.x
In Commercial Distribution

  • 03770024774016 ()


  • 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

Rayvolve - 03770018071015

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 : Full Cloud)
AZMED
2
In Commercial Distribution

  • 03770018071015 ()


  • X-ray image interpretive software
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