Cleared Traditional

K240593 - VEEGix EEG System (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240593 · Neuroservo, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
175d
Days
Class 2
Risk

K240593 is an FDA 510(k) clearance for the VEEGix EEG System. Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Neuroservo, Inc. (Montreal, CA). The FDA issued a Cleared decision on August 23, 2024 after a review of 175 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 Neuroservo, Inc. devices

Submission Details

510(k) Number K240593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2024
Decision Date August 23, 2024
Days to Decision 175 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
27d slower than avg
Panel avg: 148d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 53
Devices cleared under the same product code (OLT) and FDA review panel - the closest regulatory comparables to K240593.
HippoMind (v1.0)
K251881 · Hippoclinic · Dec 2025
EEG-1260A Neurofax System (EEG-1260A)
K251366 · Nihon Kohden Corporation · Oct 2025
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
K220254 · Neurosoft , Ltd. · Nov 2022
Wireless EEG System
K213299 · Pascall Systems, Inc. · May 2022