# K062015: Chronos Vision Eye Tracking Device (C-Etd)

- Pathway: 510(k) (Traditional)
- Applicant: Chronos Vision
- Decided: Oct 31, 2006 after 106 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964325: Visualeyes: Video Eye Monitor, Micromedical Technologies, Inc. (1997) Summary page 1.
- K972243: 2D Vog - Video-Oculography, Sensomotoric Instruments, GmbH (1997) Summary page 1.
- K042529: Balanceback VNG System, Fall Prevention Technologies, LLC (2004) Summary page 1.
- K050098: Ddat Omt, Ddat (Uk), Ltd. (2005) Summary page 1.
- K925111: House Infrared/Video Electronystagmograph System, Eye Dynamics, Inc. (1994) Summary page 1.

## Indications for use
The Chronos Vision Eye Tracking Device (C-ETD) is intended to provide information to assist in the diagnosis of vestibular disorders by measuring, recording, storing, displaying, and analyzing nystagmus of the eye. The C-ETD is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.

Source page: https://510kreport.com/device/K062015
Methodology: https://510kreport.com/methodology