# K061791: Focus VNG/Eng Type 1068

- Pathway: 510(k) (Traditional)
- Applicant: Gn Otometrics A/S
- Decided: Jul 11, 2006 after 15 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 K991497 (1999). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991497: Ics Medical Chartr Eng/VNG Diagnostic System, Ics Medical Corp. (1999) Summary page 1.

## Most influential descendants
- K151504: ICS Impulse (2015), 3 descendants of its own
- K242198: ICS Dizcovery (1091) (2025), 0 descendants of its own
- K242726: Synapsys VHIT (2025), 0 descendants of its own
- K163270: ISEN-Goggles with Data Viewer (2017), 0 descendants of its own

## Indications for use
The Focus VNG/ENG is a nystagmograph that is intended to measure, record, and display involuntary movements (nystagmus) of the eyeball.

Source page: https://510kreport.com/device/K061791
Methodology: https://510kreport.com/methodology