# K083603: I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal Video Nystagmography System (VNG), I-Portal Neuro Otol

- Pathway: 510(k) (Traditional)
- Applicant: Neuro Kinetics
- Decided: Aug 6, 2009 after 244 days
- Product code: GWN (Nystagmograph)
- Device class: 2
- Regulation: 21 CFR 882.1460
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K143607: I-Portal NOTC, VNG and VOG (2015), 4 descendants of its own
- K171884: I-Portal Portable Assessment System - Nystagmograph (I-PAS) (2017), 1 descendant of its own
- K243709: NeuroEars-Anna™ (2025), 0 descendants of its own
- K192186: I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph (2019), 0 descendants of its own
- K181025: I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System (2018), 0 descendants of its own

## Recalls of this device
- Jul 21, 2015 · Class II · Z-2730-2015: The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.
- Apr 30, 2015 · Class II · Z-1795-2015: complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.
- Nov 21, 2013 · Class II · Z-0966-2014: The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process.
- Jul 24, 2009 · Not classified · Z-2253-2009: Marketed without a 510k or PMA submission to include the normative data display.

## 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. I-Portal® 4D Video Oculography (VOG) System is used to monitor and record eye movements from various stimuli used in vestibular diagnostic testing. The system measures and records horizontal, vertical, and torsional eye movements, as well as pupil area. It is used in conjunction with various stimuli (rotary chair, manual (done by clinician) positional maneuvers, caloric tests, external stimulus) to detect and record nystagmus and eye tracings for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations. I-Portal® Video-Nystagmography System (VNG) is used in vestibular and neuro otologic diagnostic testing. The VNG provides stimuli to a patient through 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/K083603
Methodology: https://510kreport.com/methodology