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) → OLY — Magnetoencephalograph

# OLY · Magnetoencephalograph

_Neurology · 21 CFR 882.1400 · Class 2_

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

## Overview

- **Product Code:** OLY
- **Device Name:** Magnetoencephalograph
- **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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K191785](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLY/K191785.md) | Orion LifeSpan MEG | Compumedics Limited | Feb 14, 2020 | SESE |
| [K152184](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLY/K152184.md) | MagView BIOMAGNETOMETER SYSTEM | Tristan Technologies, Inc. | Apr 8, 2016 | SESE |
| [K133419](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLY/K133419.md) | BABYMEG BIOMAGNETOMETER SYSTEM | Tristan Technologies, Inc. | Jul 21, 2014 | SESE |
| [K962317](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLY/K962317.md) | MAGNES 2500 WH BIOMAGNETOMETER | Biomagnetic Technologies, Inc. | May 7, 1997 | SESE |
| [K962764](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLY/K962764.md) | NEUROMAG-122 | Philips Medical Systems (Cleveland), Inc. | Oct 31, 1996 | SESE |
| [K854466](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLY/K854466.md) | BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER | Biomagnetic Technologies, Inc. | Feb 4, 1986 | SESE |

## Top Applicants

- Biomagnetic Technologies, Inc. — 2 clearances
- Tristan Technologies, Inc. — 2 clearances
- Compumedics Limited — 1 clearance
- Philips Medical Systems (Cleveland), Inc. — 1 clearance

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

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