PathPresenter Clinical Viewer
PathPresenter CorporationPathPresenter Clinical Viewer is a web-based software tool designed to help pathologists view and manage high-resolution digital images of tissue slides. It facilitates diagnosis by allowing detailed image navigation, annotation, and measurement, improving pathology workflow and accuracy.
Intended Use
Software intended for viewing and managing whole slide images of scanned glass slides derived from formalin fixed paraffin embedded (FFPE) tissue. Aid to pathologists to review and render diagnosis using digital images for primary diagnosis.
Technology
Web-based digital pathology image management platform that receives whole slide NDPI images from Hamamatsu NanoZoomer S360MD scanner and allows zooming, panning, measuring, annotating, and retrieving images via browser interface.
Performance
Tested for pixelwise image equivalence to predicate device with less than 3 ΔE00 color difference; meeting turnaround time targets for image loading and manipulation; measurement tools with zero error in length and area across magnifications; human factors testing confirms safe, accurate clinical use by pathologists.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/31/2025
2 months - 2
FDA Approval
6/20/2025
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