# K200534: VisualEyes

- Pathway: 510(k) (Traditional)
- Applicant: Interacoustics A/S
- Decided: Aug 12, 2020 after 163 days
- Product code: GWN (Nystagmograph)
- Device class: 2
- Regulation: 21 CFR 882.1460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K972243 (1997). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163149: VisualEyes, Interacoustics A/S (2017) Summary page 5.

## Most influential descendants
- K223047: NeuroSwift Pro (2023), 0 descendants of its own

## Indications for use
The VisualEyes system provides information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders. Nystagmus of the eye is recorded by use of a goggle mounted with cameras. These images are measured, recorded, displayed and stored in the software. This information then can be used by a trained medical professional to assist in diagnosing vestibular disorders. The target population for VisualEyes system is 5 years of age and above

Source page: https://510kreport.com/device/K200534
Methodology: https://510kreport.com/methodology