FDA Radiology AI Devices

AISight Dx is a software-only, web-based digital pathology image viewing and management system designed to aid pathologists in viewing, interpreting, and managing digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It supports images from scanners such as the Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX. The software allows pathologists to zoom, pan, measure, and annotate whole slide images to assist in primary diagnosis while ensuring image quality through built-in quality controls.

CaloPix is a software-only digital pathology image management system designed to help pathologists view, interpret, and manage whole slide images from scanned surgical pathology slides of formalin-fixed paraffin embedded tissue. It supports detailed image review including panning, zooming, annotation and measurement and integrates with laboratory systems to organize pathology cases digitally. The software assists clinicians in efficiently handling large digital slide datasets to aid in primary diagnosis.

Viewer+ is an internet browser-based software intended to help pathologists view and manage digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded tissue. It aids in primary diagnosis by allowing image navigation, annotation, and measurement, ultimately supporting pathology evaluations digitally.

FullFocus is a web-based software that enables pathologists to view, navigate, and manage digital images of scanned surgical pathology slides prepared from FFPE tissue. It helps pathologists review images for primary diagnosis by providing tools like zooming, panning, measurement, and annotation, improving diagnostic workflow and accuracy.

MetaLite DX Digital Pathology Software is a software-only medical device that helps pathologists view, interpret, and manage digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded tissue. It facilitates digital pathology diagnosis by providing tools for image viewing, zooming, measurements, and annotation, designed to enhance workflow with specific scanners and displays, thereby aiding in accurate and efficient pathology diagnosis.