Roche announced that its whole slide imaging system, Roche Digital Pathology Dx, has received an additional 510(k) clearance from the United States Food and Drug Administration (FDA).
This clearance modifies the one Roche received on June 14, 2024, for Roche Digital Pathology Dx, which includes the VENTANA DP 200 slide scanner, Roche’s digital pathology workflow software and a display, and now adds the VENTANA DP 600 slide scanner.
The VENTANA DP 600 has 40 times the capacity of the VENTANA DP 200 and uses the same scanning technology, providing pathologists with consistent, high-quality images from both systems. Roche Digital Pathology Dx now includes the VENTANA DP 200 slide scanner, the VENTANA DP 600 slide scanner, Roche’s digital pathology workflow software and a display.
Roche Digital Pathology Dx is intended to aid the pathologist in reviewing and interpreting digital images of scanned pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue when diagnosing patients.