# K260566: SMARTVERTIGO™ Vestibular Assessment System

- Pathway: 510(k) (Traditional)
- Applicant: VertigoDx, Inc.
- Decided: Jul 30, 2026 after 161 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: 2 generations back to K964325 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182214: DizzyDoctor System 1.0.0, Dizzydoctor Systems, LLC (2018) Summary page 6.

## Indications for use
The SmartVertigo™ Vestibular Assessment System is indicated for use in the medical office, hospital, and healthcare settings for viewing and recording eye movements in patients with symptoms of dizziness caused by peripheral vestibular disorders who are under the supervision of a clinician. The device records abnormal eye movements with an iPhone camera in response to standard positional maneuvers. The device records, tracks, stores, and displays normal and abnormal eye movements, including vertical, horizontal, and torsional. This device provides no diagnosis and does not provide diagnostic recommendations. The target population is individuals 12 years of age and older.

Source page: https://510kreport.com/device/K260566
Methodology: https://510kreport.com/methodology