510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K083603Substantially Equivalent

I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal Video Nystagmography System (Vng), I-Portal Neuro Otol

Spryson America Inc, Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K083603 is the FDA 510(k) clearance record for I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL, a class II device, cleared for Neuro Kinetics on under FDA product code GWN (Nystagmograph). FDA records list 4 510(k) clearances for Spryson America Inc, from to . As of , FDA records show 4 recalls naming K083603.

Clearance record

Decision date
Received
(244 days to decision)
Product code
GWN Nystagmograph
Regulation
21 CFR 882.1460
Device class
Class II
Review panel
Neurology
Applicant
Neuro Kinetics 128 Gamma Dr., Pittsburgh PA
510(k) summary
Statement
Third party review
No

Clearances, product code GWN

Trailing 12 months
1 clearance under product code GWN in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GWN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260