# K982103: Ulmer (VNG) Video Nystagmograph

- Pathway: 510(k) (Traditional)
- Applicant: Synapsys, Inc.
- Decided: Sep 11, 1998 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K163558: Synapsys Ulmer Video Nystagmograph (2017), 0 descendants of its own
- K070670: Eyetracker/Ideas (2007), 0 descendants of its own

## Indications for use
The Ulmer Video Nystagmograph System is intended for use by the physician as an aid for the detection and diagnosis of vestibular disorders. The Ulmer VNG detects and displays eye position and movement in response o a number of vestibular stimulations, i.e. saccadic test, smooth pursuit, optokinetic nystagmus, caloric tests, and kinetic vestibular tests. The Ulmer VNG records and analyzes the bilateral, monocular, horizontal, and vertical aspects of eye position and movement. This device is intended to be used in a doctor’s office or health care facility to obtain recorded data of nystagmus by directly observing eye motion by video-cameras. The resulting recorded data is evaluated by a trained physician and considered along with other relevant data in diagnosing vestibular disorders.

Source page: https://510kreport.com/device/K982103
Methodology: https://510kreport.com/methodology