# K232879: Roche Digital Pathology Dx (VENTANA DP 200)

- Pathway: 510(k) (Traditional)
- Applicant: Ventana Medical Systems, Inc.
- Decided: Jun 14, 2024 after 270 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: 2 generations back to DEN160056 (2017). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190332: Aperio AT2 DX System, Leica Biosystems Imaging, Inc. (2019) Summary page 4.

## Most influential descendants
- K242783: Roche Digital Pathology Dx (2024), 0 descendants of its own

## 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 (VENTANA DP 200) is an automated digital slide creation, viewing and management system. Roche Digital Pathology Dx (VENTANA DP 200) 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 (VENTANA DP 200) is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. Roche Digital Pathology Dx (VENTANA DP 200) 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 (VENTANA DP 200) is composed of VENTANA DP 200 slide scanner, Roche uPath enterprise software, and the 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 (VENTANA DP 200).

Source page: https://510kreport.com/device/K232879
Methodology: https://510kreport.com/methodology