# K972631: Ics Medical Vemr Video Eye Movement Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Ics Medical Corp.
- Decided: Sep 22, 1997 after 70 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) House InfraRed/Video Electronystagmograph System: named in the summary without a submission number

## Most influential descendants
- K152727: ISEN-Goggles (2016), 0 descendants of its own

## Indications for use
This device is used to record and visually display movements of the eyes including nystagmus.

Source page: https://510kreport.com/device/K972631
Methodology: https://510kreport.com/methodology