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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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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

Triage Stroke - B720BX360TRIAGESTRO1120

No Description
BRAINOMIX LIMITED
11.2
In Commercial Distribution

  • B720BX360TRIAGESTRO1120 ()


  • X-ray image interpretive software

Triage LVO - B720BX360TRIAGELVO1110

No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360TRIAGELVO1110 ()


  • X-ray image interpretive software

Triage ICH - B720BX360TRIAGEICH1110

No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360TRIAGEICH1110 ()


  • X-ray image interpretive software

e-MRI - B720BX360EMRI1110

No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360EMRI1110 ()


  • X-ray image interpretive software

e-Lung - B720BX360ELUNG210

No Description
BRAINOMIX LIMITED
2.1
In Commercial Distribution

  • B720BX360ELUNG210 ()


  • X-ray image interpretive software

e-Lung - B720BX360ELUNG100

No Description
BRAINOMIX LIMITED
1.0
In Commercial Distribution

  • B720BX360ELUNG100 ()


  • X-ray image interpretive software

e-CTP - B720BX360ECTP1110

No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360ECTP1110 ()


  • X-ray image interpretive software

Brainomix 360 e-CTA - B720BX360ECTA1130

No Description
BRAINOMIX LIMITED
11.3
In Commercial Distribution

  • B720BX360ECTA1130 ()


  • X-ray image interpretive software

e-CTA - B720BX360ECTA1110

No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360ECTA1110 ()


  • X-ray image interpretive software

e-ASPECTS - B720BX360EASPECTS113

No Description
BRAINOMIX LIMITED
11.3
In Commercial Distribution

  • B720BX360EASPECTS113 ()


  • X-ray image interpretive software

e-ASPECTS - B720BX360EASPECTS1110

No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360EASPECTS1110 ()


  • X-ray image interpretive software

Annalise Triage - G140ANNALISEENTP50

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

Genoray - 08809244060137

No Description
GENORAY CO., LTD.
Zenis
In Commercial Distribution

  • 08809244060137 ()


  • X-ray image interpretive software

Critical Care Suite - 00195278789365

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 - 00195278217981

Critical Care Suite 2.0, Designated Medical Device
GE MEDICAL SYSTEMS, INC.
2.0
In Commercial Distribution

  • 00195278217981 ()


  • X-ray image interpretive software
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