700 Series Biomagnetometer

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

510(k) Number

K901215 ↗

FDA product code

OLX

Device class

Class II

Regulation

21 CFR Part 882.1400

Advisory committee

Neurology

FDA decision

SESE Substantially Equivalent

• Generator, Biotec 876 Pulse

  Not classified

  FDA 510(k) K790031 Active Cleared 2 Jan 1979

• Ibt Model Svi

  Class II

  FDA 510(k) K921821 Active Cleared 2 Nov 1992

• Magnes 2500 Wh Biomagnetometer

  Class II

  FDA 510(k) K962317 Active Cleared 7 May 1997

• Somatosensory Stimulus System

  Class II

  FDA 510(k) K913604 Active Cleared 9 Dec 1991

• Magnes II Biomagnetometer

  Class II

  FDA 510(k) K941553 Active Cleared 16 May 1996

• Biomagnetic Technologies Neuromagneometer

  Class II

  FDA 510(k) K854466 Active Cleared 4 Feb 1986

See all devices from Biomagnetic Technologies, Inc. →

• What clinical applications is the 700 Series Biomagnetometer primarily used for in neurology settings?

  The 700 Series Biomagnetometer is designed to assist in localizing and analyzing functional brain sources by measuring and processing biomagnetic signals from neural activity. It supports advanced neuroimaging studies, particularly in research and clinical settings, by detecting weak magnetic fields produced by neuronal currents. This aids in understanding brain function, often used alongside EEG or MEG platforms for precise source localization.

• Is the 700 Series Biomagnetometer intended for single-use or reusable applications, and what maintenance is required?

  The 700 Series Biomagnetometer is supplied as a reusable instrument, not single-use. Since it is a standalone or integrated system for biomagnetic signal processing, it requires specialized calibration and maintenance procedures to ensure accurate performance. Regular upkeep is essential for sustained functionality in clinical or research environments.

• How was the regulatory pathway for the 700 Series Biomagnetometer determined, and which advisory committee reviewed it?

  The device underwent a Traditional 510(k) Review pathway and received FDA clearance under K901215. Its Substantially Equivalent (SESE) determination was reviewed by the Neurology (NE) Advisory Committee, confirming its compliance with existing standards for source localization software in electroencephalography or magnetoencephalography applications.

• What types of settings can the 700 Series Biomagnetometer be used in, and how is it typically integrated?

  The 700 Series Biomagnetometer is intended for use in both clinical and research settings, where it operates either as a standalone system or integrated with EEG/Magnetoencephalography (MEG) platforms. Its design supports advanced neuroimaging workflows by enhancing signal detection and source localization for brain activity analysis.