Cleared Traditional

K191322 - E-EEGX

K191322 is an FDA 510(k) clearance for E-EEGX, manufactured by GE Healthcare Finland Oy. The device is a Class 2 Neurology device with product code OLT cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K191322 · GE Healthcare Finland Oy · Neurology device
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Jan 2020
Decision
252d
Days
Class 2
Risk

K191322 is an FDA 510(k) clearance for the E-EEGX, N-EEGX. Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on January 22, 2020 after a review of 252 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all GE Healthcare Finland Oy devices

FDA 510(k) Submission Details - K191322

510(k) Number K191322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2019
Decision Date January 22, 2020
Days to Decision 252 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 148d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLT Device Classification - Class 2, Special Controls

Product Code OLT Non-normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - OLT Non-normalizing Quantitative Electroencephalograph Software

All 19
Devices cleared under the same product code (OLT) and FDA review panel - the closest regulatory comparables to K191322.
VEEGix EEG System
K240593 · Neuroservo, Inc. · Aug 2024
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
K220254 · Neurosoft , Ltd. · Nov 2022
Wireless EEG System
K213299 · Pascall Systems, Inc. · May 2022
CNS Envision
K192572 · Moberg Research, Inc. · Dec 2019
Cadwell Bolt Software
K190760 · Cadwell Industries, Inc. · Nov 2019
NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
K080546 · Nihon Kohden America, Inc. · Aug 2008