# K152112: VisualEyes

- Pathway: 510(k) (Traditional)
- Applicant: Interacoustics A/S
- Decided: Dec 29, 2015 after 153 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: 2 generations back to K972243 (1997). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072254: VN415M, VN415B, VO425M, V0425B, 2D-Vog Goggles, 2D-Vog System, Interacoustics A/S (2008) Summary page 4.
- K964646: Video Eye Trakker, Micromedical Technologies, Inc. (1997) Summary page 4.

## Most influential descendants
- K163149: VisualEyes (2017), 2 descendants of its own
- K200534: VisualEyes (2020), 1 descendant of its own
- K223047: NeuroSwift Pro (2023), 0 descendants of its own
- K203082: Insight Infrared Video Goggles (2020), 0 descendants of its own

## Indications for use
The VisualEyes 515/ VisualEyes 525 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 515/525 system is 5 years of age+

Source page: https://510kreport.com/device/K152112
Methodology: https://510kreport.com/methodology