Viewer+
Lumea, Inc.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.
Intended Use
Software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue to aid primary diagnosis.
Technology
Web-based software that facilitates viewing and navigation of digitized pathology images from Hamamatsu NanoZoomer S360MD Slide scanner, supports image zoom, pan, annotation, measurement and case management, operating with BARCO MDPC-8127 display.
Performance
Performance testing demonstrated that Viewer+ produces pixel-wise identical images compared to predicate software, has adequate image navigation speed, accurate measurement capabilities, and passed usability testing per FDA guidance, confirming safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/31/2024
7 months - 2
FDA Approval
3/14/2025
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