# K223047: NeuroSwift Pro

- Pathway: 510(k) (Traditional)
- Applicant: Neurobit Technologies Co., Ltd.
- Decided: Jun 29, 2023 after 273 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: 5 generations back to K972243 (1997). 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)
- K200534: VisualEyes, Interacoustics A/S (2020) Summary page 6.

## Indications for use
NeuroSwift Pro is intended for Viewing and recording eye movements in support of identifying vestibular disorders.The system is to be used by trained healthcare personnel in an appropriate healthcare setting. This system provides no diagnosis and does not provide diagnostic recommendations. The target population is 12+ years of age.

Source page: https://510kreport.com/device/K223047
Methodology: https://510kreport.com/methodology