# K242783: Roche Digital Pathology Dx

- Pathway: 510(k) (Special)
- Applicant: Ventana Medical Systems, Inc.
- Decided: Dec 17, 2024 after 92 days
- Product code: PSY (Whole Slide Imaging System)
- Device class: 2
- Regulation: 21 CFR 864.3700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN160056 (2017). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232879: Roche Digital Pathology Dx (VENTANA DP 200), Ventana Medical Systems, Inc. (2024) Summary page 5.

## Recalls of this device
- Apr 20, 2026 · Class II · Z-2913-2026: Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window

## Indications for use
Roche Digital Pathology Dx is an automated digital slide creation, viewing and management system. Roche Digital Pathology Dx is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of scanned pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue. Roche Digital Pathology Dx is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. Roche Digital Pathology Dx is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. Roche Digital Pathology Dx is composed of VENTANA DP 200 slide scanner, VENTANA DP 600 slide scanner, Roche uPath enterprise software, and ASUS PA248QV display. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using Roche Digital Pathology Dx.

Source page: https://510kreport.com/device/K242783
Methodology: https://510kreport.com/methodology