E1000 Dx Digital Pathology Solution
Shandon Diagnostics LimitedThe Epredia E1000 Dx Digital Pathology Solution is an automated system that creates, views, and manages digital images of surgical pathology slides prepared from formalin-fixed paraffin-embedded tissue. It helps pathologists interpret tissue samples digitally, providing an alternative to traditional light microscopy and improving workflow and diagnostic accuracy in pathology labs.
Intended Use
The Epredia E1000 Dx Digital Pathology Solution is an automated digital slide creation, viewing, and management system intended for in vitro diagnostic use as an aid to pathologists to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is not intended for frozen section, cytology, or non-FFPE hematopathology specimens.
Technology
The system includes a high-capacity automated scanner that generates images in MRXS file format, scanner software, an image management system, viewer software, and a high-resolution display. It scans FFPE tissue slides to create whole slide digital images, which are then managed and reviewed via dedicated software on a display monitor. It supports slide feeder capacity of up to 1,000 slides and includes image processing, composition, and management software.
Performance
Performance was validated through technical studies (including hardware/software component tests), user interface and human factors validation studies, electromagnetic compatibility testing, and clinical accuracy studies comparing digital image interpretation to optical microscopy. The clinical study showed substantial equivalence with low major discordance rates. Precision studies demonstrated high repeatability and reproducibility across systems and sites.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/14/2024
8 months - 2
FDA Approval
2/28/2025
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.