ClariSIGMAM automatically analyzes “for presentation” 2D digital mammograms to assess breast tissue composition. The software assesses the breast density of women and generates a breast density group information for the patient in accordance with the American College of Radiology’s Breast Imaging Reporting and Data System (BI-RADS) 5th edition density classification scale.
Images shown for illustrative purposes only.
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~26% and ~20% faster nodule search time
ClearRead CT technology helps radiologists see through the complexity to better detect abnormalities.1,2
Higher inter-reader agreement rates2
For CalanticTM software version 1.0.0 and older versions, no prior study will be examined.
2D digital mammograms Series: cranio-caudal (CC)or medio-lateral oblique (MLO)
The report summarizes the results of the breast density analysis. It contains patient information, mammography images with a pink overlay, and tables displaying results that includes:
- Breast area (cm2) for each breast
- Fibroglandular tissue area (cm2) for each breast
- Percent breast density for each breast
- Breast Density Category according to the BI-RADS 5th edition.
Currently not made available with Calantic Viewer. Separately distributed by Bayer.
EU risk class and CE marking
ClariSIGMAM has CE marking (CE2460) and risk class Im.
No contraindications given.
Trained and experienced medical professionals including but not limited to radiologist and radiology technologist.
To ensure correct results are received and for avoidance of doubt, ClariSIGMAM cannot be used on the following images (note that this is not an exhaustive list):
- ‘For processing’ mammography images.
- Contrast enhanced mammography images.
- Cleavage views.
- Medial Lateral or Lateral Medial views.
- Image including implants.
- Spot or Magnification views.
- Images obtained with a small compression paddle that results in breast tissue being obstructed by compression device frame or tissue outside of compression paddle.
- Images including guidance wires or markers.
If any of these images are processed with ClariSIGMAM, erroneous results may be generated.