Compliance - AGFA CR 85-XTM User Manual

14 | CR Mammography | Introduction to the CR Mammography System

Compliance

Agfa has performed a clinical study for diagnostic mammography.
Regulatory requirements for digital mammography are still changing in many
countries; therefore, Agfa cannot guarantee that the use of the CR
Mammography System will be in compliance with evolving requirements.
The CR Mammography System is marked with the CE-label:
2344Q EN 20180406 1001
Note:
Manufacturer Declaration for the System and Declaration of
Conformity for the different components are available.
The CE-label is conform the Medical Device Directive (MDD)
93/42/EEC for a class IIa system.
European Notified Body approval is obtained.