Medical Image Viewing and Management Software - Vietnam Registration 240001561/PCBA-HCM

For In Vitro Diagnostic Use HALO AP is a software application that is used to view and manage digital images of hematoxylin and eosin (H&E) stained surgical tissue sections that have been fixed with formalin and embedded in paraffin (FFPE). It is a tool to assist the pathologist in the interpretation of the images. The pathologist will then review and interpret the images before rendering the initial diagnostic impression. HALO AP is not intended for use with frozen tissue, cytology, or non-FFPE blood specimens. The responsibility of the pathologist is to use appropriate procedures and appropriate safeguards to ensure the accurate interpretation of the images obtained and, if necessary, to use conventional light microscopy to review and make the diagnostic decision. HALO AP is designed to be used with image scanners and display monitors that have been qualified using established test methods to meet the required performance specifications. Pathologists should use HALO AP in conjunction with their complete standard of care for the entire light microscopic image.