Intended Use; Indications For Use; Authorized Users; Patient Population - Siemens SOMATOM Emotion Quick Manual

1 Introduction
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1.1

Intended use

SOMATOM Emotion is a computed tomography system. This
computed tomography system is intended to generate and process
cross-sectional images of patients by computer reconstruction of X-
ray transmission data. The images delivered by the system can be
used by a trained physician as an aid in diagnosis.

Indications for use

1.2
This computed tomography system is intended to generate and
process cross-sectional images of patients by computer
reconstruction of x-ray transmission data.
The images delivered by the system can be used by a trained
physician as an aid in diagnosis.
The images delivered by the system can be used by trained staff as
an aid in diagnosis and treatment preparation.
This CT system can be used for low dose lung cancer screening in
high risk populations.
* As defined by professional medical societies. Please refer to clinical
literature, including the results of the National Lung Screening Trial
(N Engl J Med 2011; 365:395-409) and subsequent literature, for
further information.
1.3

Authorized users

SOMATOM Emotion must be used by persons with the necessary
specialist knowledge, for example, doctors, trained radiologists, or
trained technologists, after appropriate application training.
United States Federal law restricts this device for sale by or on the
order of a physician (21 CFR 801.109(b)(1)).
1.4

Patient population

No patient population restrictions are known.
*
Print No. HC-C2-025.626.01.01.02
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