MetaLite DX Digital Pathology Software
JelloX Biotech Inc.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.
Intended Use
Software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded tissue for pathology primary diagnosis aid.
Technology
Software enables viewing, interpretation, and management of whole slide images in Philips proprietary iSyntax format acquired by Philips Ultra Fast Scanner, including tools for image adjustment, measurement, annotation, and panning; compatible with Barco MDPC-8127 display.
Performance
Performance testing included pixel-wise image comparison demonstrating pixel-wise identity to predicate device images, measurement accuracy verified with calibration slides, turnaround image loading times under 5 seconds, and usability testing per FDA human factors guidance showing safety and effectiveness for intended use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/2/2024
8 months - 2
FDA Approval
10/28/2024
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