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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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Imbio PHA - 00850894007902

The PHA Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The PHA Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal.
Imbio, LLC
4.0.0
In Commercial Distribution

  • 00850894007902 ()


  • X-ray image interpretive software

RBknee - 05700002173614

No Description
Radiobotics ApS
v.1.
In Commercial Distribution

  • 05700002173614 ()


  • 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

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

Brainomix 360 e-CTA - B720BX360ECTA1130

No Description
BRAINOMIX LIMITED
11.3
In Commercial Distribution

  • B720BX360ECTA1130 ()


  • X-ray image interpretive software
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