Interpretive software IVDs

Intended purpose

Sectra Digital Pathology Module is intended for primary diagnosis as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue, frozen sections or cytology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using Sectra Digital Pathology Module.