Intended Use

Viewer is a software device for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements and 3D visualization (Multiplanar Reconstructions and 3D volume rendering). It is not intended for primary image diagnosis or the review of mammographic images.

Intended User

The device is generally used by medical professionals such as doctors, their assistants or nursing staff which are in need of displaying medical (DICOM) images and other healthcare data for non-diagnostic purposes.

The user profile for Viewer is independent of specific clinical use cases.

Place of Use

The place of use is determined to be indoors, normally in a hospital or clinical setting.

Patient Population

The device is software which allows viewing of DICOM data. Hence there is no specific patient population.

Plausibility Review

Responsibility

Only trained medical personnel may operate system components and accessory instrumentation.