# K181025: I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System

- Pathway: 510(k) (Special)
- Applicant: Neuro Kinetics, Inc.
- Decided: Jul 24, 2018 after 97 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 K083603 (2009). 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)
- K143607: I-Portal NOTC, VNG and VOG, Neuro Kinetics, Inc. (2015) Summary page 4.

## Indications for use
I-Portal® Neuro Otologic Test Center (NOTC) is a rotary chair system used in vestibular and neuro-otologic diagnostic testing. The NOTC provides stimuli to a patient through motion profiles and/or visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.

Source page: https://510kreport.com/device/K181025
Methodology: https://510kreport.com/methodology