Skip to content

MEGVISION, Model EQ1000C Series

by Eagle Technology, Inc.

510(k) K040051

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 · Traditional NumberK040051 Date24 Mar 2004ClearedStatusActive

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  • Withdrawn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, 24 Sep 2026

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

MEGVISION, Model EQ1000C Series is a source localization software for electroencephalograph or magnetoencephalograph. It measures magnetic signals from intercellular dendritic currents in the brain cortex and utilizes a helmet-shaped array of up to 320 dc-SQUID axial gradiometers. The system processes signals via PCs and data acquisition software, using a superconducting flux transformer coupled with dc-SQUID driven by a digitally controlled analog flux-locked loop circuit.

The device is supplied as part of a system that displays output for clinicians. It is authorized under FDA 510(k) clearance with product code OLX and device class 2. The system includes multiple FEI numbers and registration numbers, indicating its regulatory compliance for neurology applications.

Questions

AI-generated answers, 24 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 MEGVISION EQ1000C Series used for?

    The MEGVISION EQ1000C Series is a source localization software designed for electroencephalograph (EEG) or magnetoencephalograph (MEG) applications. It measures magnetic signals from intercellular dendritic currents in the brain cortex to help clinicians localize brain activity sources.

  • How is the MEGVISION EQ1000C Series supplied?

    The device is supplied as part of a complete system that includes the source localization software, a helmet-shaped array of up to 320 dc-SQUID axial gradiometers, and data acquisition software for processing signals via PCs. The system displays output for clinicians to use.

  • What is the regulatory status of the MEGVISION EQ1000C Series?

    The MEGVISION EQ1000C Series is authorized under FDA 510(k) clearance with product code OLX and device class 2. It has multiple FEI numbers and registration numbers, indicating its regulatory compliance for neurology applications.

  • How does the MEGVISION EQ1000C Series process brain signals?

    The system processes brain signals using a superconducting flux transformer coupled with dc-SQUID driven by a digitally controlled analog flux-locked loop circuit. It utilizes a helmet-shaped array of up to 320 dc-SQUID axial gradiometers to measure magnetic signals from the brain cortex.