Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1400](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1400) → OLU — Normalizing Quantitative Electroencephalograph Software

# OLU · Normalizing Quantitative Electroencephalograph Software

_Neurology · 21 CFR 882.1400 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLU

## Overview

- **Product Code:** OLU
- **Device Name:** Normalizing Quantitative Electroencephalograph Software
- **Regulation:** [21 CFR 882.1400](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1400)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **3rd-party reviewable:** yes

## Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K240420](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLU/K240420.md) | NeuroField Analysis Suite | Neurofield, Inc. | Sep 20, 2024 | SESE |
| [K222838](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLU/K222838.md) | iSyncBrain©-C | iMediSync, Inc. | Mar 16, 2023 | SESE |
| [K212684](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLU/K212684.md) | BrainView QEEG Software | Medeia, Inc. | Jan 28, 2023 | SESE |
| [K202588](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLU/K202588.md) | BNA Platform | Elminda, Ltd. | Dec 7, 2020 | SESE |
| [K191432](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLU/K191432.md) | cortiQ PRO | G.Tec Medical Engineering GmbH | Jan 24, 2020 | SESE |
| [K171414](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLU/K171414.md) | qEEG-Pro | Brainmaster Technologies, Inc. | Jul 1, 2018 | SESE |
| [K121119](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLU/K121119.md) | BNA ANALYSIS SYSTEM | Eiminda , Ltd. | Jul 25, 2014 | SESE |
| [K112077](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLU/K112077.md) | HBIDB - HUMAN BRIAN INDEX SOFTWARE | Corscience GmbH & Co. KG | Mar 9, 2012 | SESE |
| [K050192](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLU/K050192.md) | BRC SOFTWARE PRODUCT | Brc Operations Pty Limited | Oct 20, 2005 | SESE |
| [K041263](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLU/K041263.md) | NEUROGUIDE ANALYSIS SYSTEM | Applied Neuroscience, Inc. | Aug 3, 2004 | SESE |
| [K974748](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLU/K974748.md) | NEUROMETRIC ANALYSIS SYSTEM | Nxlink, Ltd. | Jul 10, 1998 | SESE |
| [K904294](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLU/K904294.md) | QSI 9500 | Quantified Signal Imaging, Inc. | Jul 30, 1991 | SESE |

## Top Applicants

- Applied Neuroscience, Inc. — 1 clearance
- Brainmaster Technologies, Inc. — 1 clearance
- Brc Operations Pty Limited — 1 clearance
- Corscience GmbH & Co. KG — 1 clearance
- Eiminda , Ltd. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLU](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLU)

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