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510(k) K083603

I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL by Neuro Kinetics — Product Code GWN

K083603 is an FDA 510(k) premarket notification submitted by Neuro Kinetics for the device "I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL". The FDA issued a decision of Substantially Equivalent on August 6, 2009. The device falls under product code GWN (Nystagmograph), a Class II device regulated under 21 CFR 882.1460. Neuro Kinetics has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2009
Date Received
December 5, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nystagmograph
Device Class
Class II
Regulation Number
882.1460
Review Panel
NE
Submission Type

Other clearances by Neuro Kinetics

  • K181025 — I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Por (July 24, 2018)
  • K171884 — I-Portal Portable Assessment System - Nystagmograph (I-PAS) (November 22, 2017)
  • K143607 — I-Portal NOTC, VNG and VOG (July 8, 2015)

Other clearances for product code GWN

  • K243709 — NeuroEars-Anna™ (August 25, 2025)
  • K242198 — ICS Dizcovery (1091) (February 14, 2025)
  • K242726 — Synapsys VHIT (January 3, 2025)
  • K223047 — NeuroSwift Pro (June 29, 2023)
  • K203082 — Insight Infrared Video Goggles (November 12, 2020)
  • K200534 — VisualEyes (August 12, 2020)
  • K192186 — I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Por (November 29, 2019)
  • K181771 — RightEye Vision System (September 28, 2018)
  • K182214 — DizzyDoctor System 1.0.0 (September 14, 2018)
  • K181025 — I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Por (July 24, 2018)

FDA data resources