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Elekta Neuromag With Maxwell Filter With Internal Active Shielding

by Elekta Neuromag OY

510(k) K081430

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK081430 Date28 Jul 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OLX
Device Class
Class II
Regulation
21 CFR Part 882.1400
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Elekta Neuromag with Maxwell Filter with Internal Active Shielding is a magnetoencephalographic device. It is designed to non-invasively detect and display biomagnetic signals produced by electrically active nerve tissue in the brain.

This device is intended for use by trained clinicians to provide information regarding the location of neural activity. It has received FDA 510(k) clearance under the neurology medical specialty.

Other devices from Elekta Neuromag OY

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Elekta Neuromag system?

    This device is a magnetoencephalograph designed to non-invasively detect and display biomagnetic signals generated by electrically active nerve tissue within the brain. It is intended to assist trained clinicians in identifying the specific location of neural activity.

  • What regulatory status does this device hold?

    The Elekta Neuromag with Maxwell Filter with Internal Active Shielding has received FDA 510(k) clearance. It is classified under the neurology medical specialty and is regulated as a source localization software for magnetoencephalographs.

  • Who is the intended user for this magnetoencephalographic device?

    The device is intended for use by trained clinicians. Because the system involves complex biomagnetic signal detection and localization, professional training is required to operate the equipment and interpret the resulting data regarding neural activity.