# K232202: Aperio GT 450 DX

- Pathway: 510(k) (Traditional)
- Applicant: Leica Biosystems Imaging, Inc.
- Decided: Apr 16, 2024 after 266 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: 2 generations back to DEN160056 (2017). 2 ancestors in all.
10 later devices descend from it; 9 cite it directly.
0 of 13 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 6.

## Most influential descendants
- K253554: Aperio GT 450 DX; Aperio GT 180 DX (2026), 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
- K251952: Virasight (2026), 0 descendants of its own
- K252762: HALO AP Dx (2025), 0 descendants of its own

## Indications for use
The Aperio GT 450 DX is an automated digital slide creation and viewing system. The Aperio GT 450 DX 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 GT 450 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. Aperio GT 450 DX is comprised of the Aperio GT 450 DX scanner, which generates images in the Digital Imaging and Communications in Medicine (DICOM) and in the ScanScope Virtual Slide (SVS) file formats, the Aperio WebViewer DX viewer, and the displays. The Aperio GT450 DX is intended to be used with the interoperable components specified in Table 1. The Aperio GT 450 DX is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. 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 GT 450 DX.

Source page: https://510kreport.com/device/K232202
Methodology: https://510kreport.com/methodology