# K192186: I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph

- Pathway: 510(k) (Traditional)
- Applicant: Neurolign USA, LLC
- Decided: Nov 29, 2019 after 109 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 K083603 (2009). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083603: I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal Video Nystagmography System (VNG), I-Portal Neuro Otol, Neuro Kinetics (2009) Summary page 3.
- K143607: I-Portal NOTC, VNG and VOG, Neuro Kinetics, Inc. (2015) Summary page 3.
- K171884: I-Portal Portable Assessment System - Nystagmograph (I-PAS), Neuro Kinetics, Inc. (2017) Summary page 3.

## Indications for use
I-Norm 100_18-45 is a quantitative tool for the comparison of patient measurements to a database of known normal subjects ages 18-45. I-Norm 100_18-45 presents data for interpretation by qualified medical personnel trained in vestibular, neurologic, neurotologic, and neuro-ophtalmic diagnostic testing. I-Norm 100_18-45 is applicable to individuals only in the 18-45 age range. The proposed intended use for I-Norm 100_18-45 is as following: I-Norm 100_18-45 is designed to be used with the family of I-Portal® devices: - I-Portal® Neuro Otologic Test Center (NOTC) (cleared by K083603, K143607) - I-Portal® Video-Nystagmography System (VNG) – SVNG-2 (cleared by K143607) - I-Portal® Portable Assessment System™ Nystagmograph (I-PAS™) (cleared by K171884) The I-Portal® devices with I-Norm 100_18-45 are nystagmograph devices intended for use in vestibular and neurotologic diagnostic testing. The addition of the I-Norm 100_18-45 does not change the intended use or the indication for use for these devices from their original clearances listed above.

Source page: https://510kreport.com/device/K192186
Methodology: https://510kreport.com/methodology