Roche Digital Pathology Dx
Ventana Medical Systems, Inc.Roche Digital Pathology Dx is a digital slide scanning and management system designed to assist pathologists by creating, viewing, and managing high-resolution digital images of pathology slides prepared from formalin-fixed paraffin-embedded tissue. It includes slide scanners and software for image acquisition and management, enabling pathologists to review digital slides instead of traditional light microscopy.
Intended Use
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 scanned pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue.
Technology
The system includes VENTANA DP 200 and DP 600 slide scanners that scan tissue specimens on slides into digital images using a high-numerical aperture 20x objective at 20x and 40x magnifications. The scanners use a shared image acquisition unit for image creation with automated tissue detection, barcode reading, and multi-layer scanning. Images are stored in a proprietary format and managed using Roche uPath enterprise software accessible via web browsers. Image quality control and workflow management functions are included.
Performance
Performance testing conducted on the predicate VENTANA DP 200 slide scanner demonstrated equivalency for the new DP 600 slide scanner in image acquisition unit hardware and software. Testing included assessment of optical performance, focus, image stitching, color reproducibility, spatial resolution, turnaround time, and user interface validation. Electromagnetic compatibility testing met standards. No additional clinical testing was required as the modified device is substantially equivalent to the predicate.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/16/2024
3 months - 2
FDA Approval
12/17/2024
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