# K190332: Aperio AT2 DX System

- Pathway: 510(k) (Traditional)
- Applicant: Leica Biosystems Imaging, Inc.
- Decided: May 20, 2019 after 95 days
- Product code: PSY (Whole Slide Imaging System)
- Device class: 2
- Regulation: 21 CFR 864.3700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN160056 (2017). 1 ancestor in all.
15 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160056: Philips IntelliSite Pathology Solution, Philips Medical Systems Nederland B.V. (2017) Summary page 4.

## Most influential descendants
- K232202: Aperio GT 450 DX (2024), 10 descendants of its own
- K253554: Aperio GT 450 DX; Aperio GT 180 DX (2026), 1 descendant of its own
- K232879: Roche Digital Pathology Dx (VENTANA DP 200) (2024), 1 descendant of its own
- K253561: Aperio iQC DX Software (2026), 0 descendants of its own
- K261380: Concentriq AP-Dx (2026), 0 descendants of its own

## Indications for use
The Aperio AT2 DX System is an automated digital slide creation and viewing system. The Aperio AT2 DX System is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The Aperio AT2 DX System is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. The Aperio AT2 DX System is composed of the Aperio AT2 DX scanner, the ImageScope DX review application and Display. The Aperio AT2 DX System is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. 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 the Aperio AT2 DX System.

Source page: https://510kreport.com/device/K190332
Methodology: https://510kreport.com/methodology