FullFocus
Paige.AI, IncFullFocus 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.
Intended Use
FullFocus is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis.
Technology
FullFocus is a web-based software-only device that facilitates the viewing and navigating of digitized pathology images from FDA cleared digital pathology scanners on specified FDA cleared displays. It uploads images and metadata to cloud storage with integrity checks, and provides pathologists the ability to zoom, pan, measure, and annotate whole slide images for diagnostic use.
Performance
Performance testing included pixel-wise comparison of image rendering against predicate image review software on multiple monitors and browsers using scanned FFPE tissue slides in different image formats. Results showed less than 3 CIEDE2000 color difference, indicating pixel-wise identical image reproduction. Additional testing validated turnaround time, measurement accuracy, and human factors usability.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/6/2024
8 months - 2
FDA Approval
1/9/2025
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