# K972243: 2D Vog - Video-Oculography

- Pathway: 510(k) (Traditional)
- Applicant: Sensomotoric Instruments, GmbH
- Decided: Sep 10, 1997 after 86 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.
12 later devices descend from it; 3 cite it directly.
0 of 13 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
- K072254: VN415M, VN415B, VO425M, V0425B, 2D-Vog Goggles, 2D-Vog System (2008), 6 descendants of its own
- K042529: Balanceback VNG System (2004), 5 descendants of its own
- K152112: VisualEyes (2015), 4 descendants of its own
- K163149: VisualEyes (2017), 2 descendants of its own
- K070729: Balanceback Mobile Intuitive VNG System (2007), 2 descendants of its own

## Indications for use
The 2D VOG -- Video-Oculography system provides information to assist in the diagnosis of vestibular disorders by measuring, recording, storing, displaying, and analyzing nystagmus of the eye.

Source page: https://510kreport.com/device/K972243
Methodology: https://510kreport.com/methodology