# K251952: Virasight

- Pathway: 510(k) (Traditional)
- Applicant: Virasoft Corporation
- Decided: Jul 17, 2026 after 387 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: 3 generations back to DEN160056 (2017). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213883: NanoZoomer S360MD Slide scanner system, Hamamatsu Photonics K.K. (2022) Summary page 5.
- K232202: Aperio GT 450 DX, Leica Biosystems Imaging, Inc. (2024) Summary page 5.

## Indications for use
ViraSight is a web-based software-only device intended to aid pathologists in the viewing and management of digital images of scanned pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue. It is an aid to the pathologist to review these digital images for the purposes of pathology primary diagnosis. ViraSight is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using ViraSight.

Source page: https://510kreport.com/device/K251952
Methodology: https://510kreport.com/methodology