CaloPix
Tribun HealthCaloPix 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.
Intended Use
CaloPix is a software only device for viewing and management of digital images of scanned surgical pathology slides prepared from Formalin-Fixed Paraffin Embedded (FFPE) tissue. It is intended for in vitro diagnostic use as an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis. It is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
Technology
CaloPix is a web-based software-only device that supports image viewing, interpretation, and management of whole slide images (WSI) obtained from specified slide scanners (Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX). The software integrates with laboratory information systems to automatically retrieve patient and case data, stores images in a CaloPix-specific file storage environment (on premises or cloud), and provides advanced image viewing functions such as panning, zooming, annotations, distance and surface measurements, and image registration.
Performance
Performance testing included pixel-wise image comparison with predicate devices showing that CaloPix reproduces images with high fidelity (color difference less than 3 CIEDE2000), measurement accuracy validated against predicate viewers, turnaround time testing for loading images within acceptable limits, and human factors usability validation confirming safety and effectiveness for intended users.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/13/2025
3 months - 2
FDA Approval
5/14/2025
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