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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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FEops - 05430002070087

FEops HEARTguide ALPACA
FEops
3.1.0
In Commercial Distribution

  • 05430002070087 ()
05430002070087

  • Radiology DICOM image processing application software

FEops - 05430002070063

FEops HEARTguide ALPACA 3.0.1 / 3.0.2
FEops
3.0.1
Not in Commercial Distribution

  • 05430002070063 ()


  • Radiology DICOM image processing application software

EchoGo - 05060634690027

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

EchoGo - 05060634690003

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 - 00850057636000

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

cmAngio - 00860006442699

cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC). cmAngio, a proprietary artificial intelligence (AI) based software, is intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC), an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms. The device also marks BAC segments on thumbnails of images for localization of BAC. The software is intended to be used by qualified interpreting physicians in parallel with breast screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection. The device results should not be used alone to make any diagnosis and/or treatment decisions.
Curemetrix, Inc.
V1.6
In Commercial Distribution

  • 00860006442699 ()


  • Radiology DICOM image processing application software

cmAngio - 00860006442682

cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC). cmAngio, a proprietary artificial intelligence (AI) based software, is intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC), an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms. The device also marks BAC segments on thumbnails of images for localization of BAC. The software is intended to be used by qualified interpreting physicians in parallel with breast screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection and should not be used alone to make any diagnosis and/or treatment decisions. cmAngio is for prescription use only.
Curemetrix, Inc.
V1.0
In Commercial Distribution

  • 00860006442682 ()


  • Radiology DICOM image processing application software

WRDensity by Whiterabbit AI - 00860005853601

Software application that uses machine learning to assess breast tissue composition.
Ai Whiterabbit Inc
WRDensity-1
In Commercial Distribution

  • 00860005853601 ()


  • Radiology DICOM image processing application software

qXR-BT - 00860005118144

The qXR-BT device is intended to generate a secondary digital chest X-ray image that facilitates confirmation of the position of a breathing tube and an anatomical landmark on adult chest X- rays. This device is intended for use by licensed physicians who are trained in the evaluation of breathing tube placement on chest X-rays. The qXR-BT image provides adjunctive information and is not a substitute for the original PA/AP image.
QURE.AI TECHNOLOGIES PRIVATE LIMITED
1.0.0
In Commercial Distribution

  • 00860005118144 ()


  • Radiology DICOM image processing application software

SpineCAMP - 00860011655701

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
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