# K182214: DizzyDoctor System 1.0.0

- Pathway: 510(k) (Traditional)
- Applicant: Dizzydoctor Systems, LLC
- Decided: Sep 14, 2018 after 30 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: 1 generation back to K964325 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964325: Visualeyes: Video Eye Monitor, Micromedical Technologies, Inc. (1997) Summary page 4.

## Most influential descendants
- K260566: SMARTVERTIGO™ Vestibular Assessment System (2026), 0 descendants of its own

## Indications for use
The DizzyDoctor® System 1.0.0 Eye Movement Monitor is indicated for use in the medical office, and in the home setting for monitoring patients with a diagnosis of dizziness caused by peripheral vestibular disorders who are under the supervision of a physician. The device detects abnormal eye movements in response to standard positional maneuvers by recording, tracking, storing and displaying vertical, horizontal and torsional eye movements. This device provides no diagnosis and does not provide diagnostic recommendations.

Source page: https://510kreport.com/device/K182214
Methodology: https://510kreport.com/methodology