# K964325: Visualeyes: Video Eye Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Micromedical Technologies, Inc.
- Decided: Jul 15, 1997 after 258 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
No predicates in its family tree.
14 later devices descend from it; 6 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K122550: Ics Impulse (2013), 4 descendants of its own
- K151504: ICS Impulse (2015), 3 descendants of its own
- K071973: Epley Omniax (2008), 3 descendants of its own
- K182214: DizzyDoctor System 1.0.0 (2018), 1 descendant of its own
- K260566: SMARTVERTIGO™ Vestibular Assessment System (2026), 0 descendants of its own

## Indications for use
The Eye Monitor is used to observe eye movements from various stimuli used in vestibular diagnostic testing. It allows observation of horizontal, vertical and torsional eye movements. The Eye Monitor is mainly used to visually detect nystagmus positional maneuvers (e.g. Hallpike (e.g. Hallpike positional tests) or caloric tests. The device is especially useful in situations where the operator needs to observe the patient's eyes to distinguish nystagmus from artifacts. These observations are currently done using Fresnel lenses. The eye movements could also be recorded on suitable media (e.g. video tape) to provide documentation for any diagnosis based on observation of the Eye Monitor.

Source page: https://510kreport.com/device/K964325
Methodology: https://510kreport.com/methodology