3Dimensions System User Guide
Chapter 1: Introduction
MAN-05085-002 Revision 002
Page 5
DRAFT
Preview Copy-Generated May 30, 2018
1.6
About C-View and Intelligent 2D
Note
Intelligent 2D™ may not be available in all regions. Contact your sales representative
for information
1.6.1
C-View and Intelligent 2D Software
The C-View
TM
and Intelligent 2D
TM
software uses image data available from a breast
tomosynthesis acquisition to generate one digital mammogram (2D) per breast
tomosynthesis acquisition. The generated 2D image is created without the need for an
additional digital mammography exposure. The generated 2D image is designed to
appear similar to, and serve the same purpose as, a digital mammogram (2D) when used
as part of a screening study employing tomosynthesis. The C-View or Intelligent 2D
image is interpreted in combination with a breast tomosynthesis image set and is not
intended to be used without the accompanying breast tomosynthesis images to make a
clinical decision or diagnosis.
1.6.2
C-View and Intelligent 2D Warnings
Warning:
Do not make a clinical decision or diagnosis from the C-View or Intelligent
2D images without reviewing the accompanying tomosynthesis image set.
Use the C-View or Intelligent 2D generated 2D images in the same way you would use
conventional digital mammography (2D) when performing a screening study employing
tomosynthesis.
•
While reviewing the C-View or Intelligent 2D images for items or areas of interest,
compare to a prior digital mammogram (2D) if priors exist and then review the
related tomosynthesis images carefully.
•
Carefully examine the entire tomosynthesis image set before making a clinical
decision.
Warning:
The appearance of a C-View or Intelligent 2D generated 2D image may differ
from that of a conventional digital mammography (2D) image, just as 2D film
and digital mammography (2D) images from different vendors may look
different.
Users should ensure they are adequately trained and are familiar with the appearance of
C-View and Intelligent 2D generated 2D images before using them in conjunction with
tomosynthesis image sets.