# K130201: Nystagram Video Nystagmography System

- Pathway: 510(k) (Traditional)
- Applicant: Ototronix, LLC
- Decided: Apr 26, 2013 after 88 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 K925111 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042529: Balanceback VNG System, Fall Prevention Technologies, LLC (2004) Summary page 2.
- K991497: Ics Medical Chartr Eng/VNG Diagnostic System, Ics Medical Corp. (1999) Summary page 2.
- K072254: VN415M, VN415B, VO425M, V0425B, 2D-Vog Goggles, 2D-Vog System, Interacoustics A/S (2008) Summary page 2.

## Indications for use
The Nystagram TM is a video nystagmograph intended to view, record, and measure eye movements in support of identification of balance disorders. The device is intended for use only by qualified, trained medical personnel to aid in diagnostic recommendations. This device does not provide any medical diagnosis and is intended to be part of a larger balance assessment battery.

Source page: https://510kreport.com/device/K130201
Methodology: https://510kreport.com/methodology