# K131681: Eyeseecam Vhit

- Pathway: 510(k) (Traditional)
- Applicant: Interacoustics A/S
- Decided: Sep 6, 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: 1 generation back to K891008 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891008: Vestibular Ocular Reflex Test Equipment (Vorteq), Micromedical Technologies, Inc. (1989) Summary page 1.
- K964325: Visualeyes: Video Eye Monitor, Micromedical Technologies, Inc. (1997) Summary page 1.

## Indications for use
The EyeSeeCam vHIT is designed to provide Information on the performance of the vestibular ocular reflex (VOR) by providing objective measures of eye-velocity response to head-velocity stimulus, showing the VOR gain in the plane of rotation of the head.

Source page: https://510kreport.com/device/K131681
Methodology: https://510kreport.com/methodology