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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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ClearPoint Maestro Brain Model Software Version 1.0
Clearpoint Neuro, Inc.
CPM-SFW-1
In Commercial Distribution

  • 00850359007966 ()
CPM-SFW-1

  • Image segmentation application software
qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans. qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm. The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities.
QURE.AI TECHNOLOGIES PRIVATE LIMITED
1.0.0
In Commercial Distribution

  • 00850057636000 ()


  • Radiology DICOM image processing application 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
Visage Imaging GmbH
1.0
In Commercial Distribution

  • 04251332930008 ()


  • Radiological PACS software
Ceevra Reveal 3+ (“Reveal 3+”), manufactured by Ceevra, Inc. (the “Company”), is a software as a medical device with two main functions: (1) it is used by Company personnel to generate three-dimensional (3D) images from existing patient CT and MR imaging, and (2) it is used by clinicians to view and interact with the 3D images during preoperative planning and intraoperatively. Clinicians view 3D images via the Reveal 3+ Mobile Image Viewer software application which runs on compatible mobile devices, and the Reveal 3+ Desktop Image Viewer software application which runs on compatible computers. The 3D images may also be displayed on compatible external displays, or in virtual reality (VR) format with a compatible off-the-shelf VR headset. Reveal 3+ includes features that enable clinicians to interact with the 3D images including rotating, zooming, panning, selectively showing or hiding individual anatomical structures, and viewing measurements of or between anatomical structures.
Ceevra, Inc.
3+
In Commercial Distribution

  • 00861625000437 ()


  • Image segmentation application software
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