SMARTVERTIGO™ Vestibular Assessment System

FDA 510(k) K260566 · VertigoDx, Inc.

Substantially Equivalent

510(k) numberK260566

Submission

Device name
SMARTVERTIGO™ Vestibular Assessment System
Applicant
VertigoDx, Inc.
Wilmington, DE, US
Received
February 19, 2026
Decision date
July 30, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWN – Nystagmograph
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1460
Specialty
Neurology

Other 510(k)s with product code GWN

510(k)DeviceApplicantDecision
K243709NeuroEars-Anna™GWN · Traditional Neuroears, Inc.08/25/2025SE
K242198ICS Dizcovery (1091)GWN · Traditional Natus Medical Denmark Aps02/14/2025SE
K242726Synapsys VHITGWN · Traditional Inventis S.R.L.01/03/2025SE
K223047NeuroSwift ProGWN · Traditional Neurobit Technologies Co., Ltd.06/29/2023SE
K203082Insight Infrared Video GogglesGWN · Traditional Vestibular First11/12/2020SE
K200534VisualEyesGWN · Traditional Interacoustics A/S08/12/2020SE
K192186I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal…GWN · Traditional Neurolign USA, LLC11/29/2019SE
K181771RightEye Vision SystemGWN · Traditional Righteye, LLC09/28/2018SE
K182214DizzyDoctor System 1.0.0GWN · Traditional Dizzydoctor Systems, LLC09/14/2018SE
K181025I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal…GWN · Special Neuro Kinetics, Inc.07/24/2018SE

Questions and answers

When was SMARTVERTIGO™ Vestibular Assessment System cleared by the FDA?

SMARTVERTIGO™ Vestibular Assessment System (K260566) received a 510(k) decision of Substantially Equivalent on July 30, 2026, 161 days after the submission was received.

What is the product code of K260566?

The FDA product code is GWN – Nystagmograph, a Class II (moderate risk) device regulated under 21 CFR 882.1460.