Intended Use - AGFA CR 85-XTM User Manual

CR Mammography | Introduction to the CR Mammography System | 11

Intended Use

Intended use for Mammography Systems based on CR 35-X/ CR 85-X; DX-M
and CR 30-Xm Digitizers
• The CR Mammography System can be used for diagnostic mammography.
• The CR Mammography System can be used for screening mammography,
in compliance to local regulations.
Intended use for Mammography Systems based on CR 25.0/ CR 75.0
Digitizers
• The CR Mammography System can be used for diagnostic mammography.
• The CR Mammography System is not intended for screening
mammography.
Diagnostic mammography
Diagnostic mammography is a radiographic examination. It is performed to
provide additional information about patients who have signs and/or
symptoms of breast disease or radiographic findings of concern. It can also be
performed in situations where direct supervision of the imaging is required by
the interpreting physician.
A diagnostic mammogram is performed under the direct supervision of a
qualified physician in mammography and may include mediolateral oblique
(MLO), craniocaudal (CC) and/or additional views.
Screening mammography
Screening mammography is a radiological examination to detect unsuspected
breast cancer in asymptomatic women. This examination may be performed
without a physician in attendance.
Note: Direct supervision is defined as the physician being
present and immediately available to furnish assistance and
direction throughout the performance of the procedure.
2344Q EN 20180406 1001