2 Product Description
2.1 Intended Use of the System
The system is intended for head, whole body, cardiac, and vascular X-ray Computed
Tomography applications.
2.2 Indications for Use of the System
The system is intended to produce cross-sectional images of the body by computer
reconstruction of X-ray transmission projection data from the same axial plane taken at different
angles. The system has the capability to image whole organs in a single rotation. Whole organs
include but are not limited to brain, heart, liver, kidney, pancreas, etc.. The system may acquire
data using Axial, Cine, Helical, Cardiac and Gated CT scan techniques from patients of all ages.
These images may be obtained either with or without contrast. This device may include signal
analysis and display equipment, patient and equipment supports, components and accessories.
This device may include data and image processing to produce images in a variety of trans-
axial and reformatted planes. Further, the images can be post processed to produce additional
imaging planes or analysis results.
The system is indicated for head, whole body, cardiac, and vascular X-ray Computed
Tomography applications.
The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality
and for planning, guiding, and monitoring therapy.
2.3 Contraindications
None known.
Revolution CT User Manual
Direction 5480385-1EN, Revision 1
Chapter 2 Regulatory Information
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