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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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SENTINEL 10 WORKSTATION (X2) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103100 ()
040-1710-00

  • Cardiology information system application software
SENTINEL 10 WORKSTATION (X1) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103094 ()
040-1709-00

  • Cardiology information system application software
ASSY CLABII PLUS64 AMP 110-240V 50/60HZ, AM 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
64 Channel
Not in Commercial Distribution

  • 00840682119634 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
ASSY CLABII PLUS128 AMP 110-240V 50/60HZ, AM 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
128 Channel
In Commercial Distribution

  • 00840682119603 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
No Description
MILVUE
V1.1.x
In Commercial Distribution

  • 03770024774047 ()


  • Radiological PACS software
No Description
GLEAMER
1.1.X
In Commercial Distribution

  • 03770020839085 ()


  • Radiological PACS software
No Description
GLEAMER
1.X-US
In Commercial Distribution

  • 03770020839009 ()


  • Radiological PACS software
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 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 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
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