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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No Description
Ezra Ai, Inc.
FLHAI01PL02IF01IT01LB02
In Commercial Distribution

  • 00860010264621 ()


  • Radiology DICOM image processing application software
Spine CAMP™ is a fully-automated image processing software device. It is designed to be used with X-ray images and is intended to aid medical professionals in the measurement and assessment of spinal parameters. Spine CAMP™ is capable of calculating distances, angles, linear displacements, angular displacements, and mathematical combinations of these metrics to characterize the morphology, alignment, and motion of the spine. These analysis results are presented in the form of reports, annotated images, and visualizations of intervertebral motion to support their interpretation.
MEDICAL METRICS, INC
SpineCAMP
In Commercial Distribution

  • 00860011655701 ()


  • Radiology DICOM image processing application software
TumorSight Viz is an image processing system designed to assist in the visualization and analysis, of breast DCE-MRI studies. TumorSight reads DICOM magnetic resonance images. TumorSight processes and displays the results on the TumorSight web application. Available features support: 1) Visualization (standard image viewing tools, MIPs, and reformats) 2) Analysis (registration, subtractions, kinetic curves, parametric image maps, segmentation and 3D volume rendering) The TumorSight system consists of proprietary software developed by SimBioSys, Inc. hosted on a cloud-based platform and accessed on an off-the-shelf computer
Simbiosys, Inc.
V1.1
In Commercial Distribution

  • 00860011523901 ()


  • Radiology DICOM image processing application software
No Description
ULTROMICS LIMITED
Core 2.0
In Commercial Distribution

  • 05060634690027 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software
No Description
ULTROMICS LIMITED
Core
In Commercial Distribution

  • 05060634690003 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system 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
Viz Subdural+ v1.1 (2025-07-10)
VIZ.AI, INC.
Viz Subdural+ Software
In Commercial Distribution

  • 00811852030363 ()


  • Radiology DICOM image processing application software
Viz ICH+ v1.3 (2025-04-06)
VIZ.AI, INC.
Viz ICH+ Software
In Commercial Distribution

  • 00811852030349 ()


  • Radiology DICOM image processing application software
Viz RV/LV v1.2 (2023-04-19)
VIZ.AI, INC.
Viz RV/LV Software
In Commercial Distribution

  • 00811852030295 ()


  • Radiology DICOM image processing application software
No Description
Siemens Healthcare GmbH
VA3
In Commercial Distribution

  • 04056869985947 ()


  • Radiology DICOM image processing application software
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