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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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FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX is indicated for adults only.
Imagen Technologies, Inc.
1.0.0
In Commercial Distribution

  • 00852491008016 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
2.2
In Commercial Distribution

  • B720BX360ELUNG220 ()


  • X-ray image interpretive software
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
The Imbio CT RV/LV 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 Imbio CT RV/LV 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
3.1.1
In Commercial Distribution

  • 00850894007766 ()


  • X-ray image interpretive software
The Imbio CT RV/LV 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 Imbio CT RV/LV 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
3.1.0
In Commercial Distribution

  • 00850894007728 ()


  • X-ray image interpretive software
The Imbio CT RV/LV 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 Imbio CT RV/LV 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
3.0.0
In Commercial Distribution

  • 00850894007643 ()


  • X-ray image interpretive software
The Imbio CT RV/LV 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 Imbio CT RV/LV 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
2.1
In Commercial Distribution

  • 00850894007636 ()


  • X-ray image interpretive software
The Imbio CT RV/LV 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 Imbio CT RV/LV 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
2.0
In Commercial Distribution

  • 00850894007605 ()


  • X-ray image interpretive software
No Description
VUNO Inc.
VN-M-30
In Commercial Distribution

  • 08800045800342 ()


  • X-ray image interpretive software
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
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