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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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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

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage - 08800045800342

No Description
VUNO Inc.
VN-M-30
In Commercial Distribution

  • 08800045800342 ()


  • X-ray image interpretive software

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

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
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