# K242726: Synapsys VHIT

- Pathway: 510(k) (Traditional)
- Applicant: Inventis S.R.L.
- Decided: Jan 3, 2025 after 115 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: 3 generations back to K991497 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151504: ICS Impulse, Gn Otometrics (2015) Summary page 5.

## Indications for use
The Synapsys VHIT is a medical device designed to assess the vestibular-ocular-reflex (VOR) by measuring, recording, displaying, and analyzing eye and head movements.

Source page: https://510kreport.com/device/K242726
Methodology: https://510kreport.com/methodology