VIDAR DiagnosticPRO Edge - Intended Use of the DiagnosticPRO Edge

19617-001 Rev. H DiagnosticPRO Edge User’s Guide 6
Intended Use
The DiagnosticPRO Edge digitizer is used for making digital copies of medical x-ray film, including
printed and radiographic film. The target users of these devices are medical professionals or trained staff
for use as secondary capture images for consultation, review and final interpretation.
The devices are indicated for the digitization of mammography images for review and analysis, but not as
the sole basis for screening or diagnosis.
Note:
 The DiagnosticPRO Edge with ClinicalExpress or other DICOM standard
software meets or exceeds ACR and DICOM standards for use of
secondary capture images for consultation, review and final interpretation.
Images captured as DICOM MG are to be used as reference or
comparison only, and not for primary diagnosis.