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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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BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360ECTP1110 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.3
In Commercial Distribution

  • B720BX360ECTA1130 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360ECTA1110 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.3
In Commercial Distribution

  • B720BX360EASPECTS113 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360EASPECTS1110 ()


  • X-ray image interpretive software
software versions 3.6.0, 3.7.0, 3.7.1, 3.8.0, 3.9.0 Annalise Triage (Annalise Critical Care AI) is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
3.6.0+
In Commercial Distribution

  • G140ANNALISEENTP50 ()
AnnaliseENTP5

  • X-ray image interpretive software
No Description
GENORAY CO., LTD.
Zenis
In Commercial Distribution

  • 08809244060137 ()


  • X-ray image interpretive software
Critical Care Suite 2.1, Designated Medical Device
GE MEDICAL SYSTEMS, INC.
2.1
In Commercial Distribution

  • 00195278789365 ()


  • X-ray image interpretive software
Critical Care Suite 2.0, Designated Medical Device
GE MEDICAL SYSTEMS, INC.
2.0
In Commercial Distribution

  • 00195278217981 ()


  • X-ray image interpretive software
CXR software versions 2.4.X+ Annalise Critical Care AI is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
CXR - 2.4+
In Commercial Distribution

  • G140ANNALISECONTAINER60 ()
Annalisecontainer6

  • X-ray image interpretive software
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