# K072254: VN415M, VN415B, VO425M, V0425B, 2D-Vog Goggles, 2D-Vog System

- Pathway: 510(k) (Traditional)
- Applicant: Interacoustics A/S
- Decided: Feb 5, 2008 after 175 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: 1 generation back to K972243 (1997). 1 ancestor in all.
6 later devices descend from it; 3 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)
- K972243: 2D Vog - Video-Oculography, Sensomotoric Instruments, GmbH (1997) Summary page 1.

## Most influential descendants
- K152112: VisualEyes (2015), 4 descendants of its own
- 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
VN415m, VN415b, VO425m, VO425b systems provide information to assist in the Oculographic evaluation, diagnosis and documentation of vestibular disorders. Nystagmus of the eye is recorded by use of goggle mounted 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.

Source page: https://510kreport.com/device/K072254
Methodology: https://510kreport.com/methodology