Search Results

The Elekta Neuromag® with MaxFilter 2.1 is intended for use as a magnetoencephalographic (MEG) device which non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. When interpreted by a trained clinician, the data enhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions. Elekta Neuromag® with MaxFilter™ non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning.

This premarket notification represents modifications made to our current product. The present device differs from the predicate device, K050035, Elekta Neuromag® with Maxwell Filter only in the following areas of functionality: Spatiotemporal interference elimination, Graphical user interface; and Offline averager. The modification also adds compatibility with internal active shielding, an interference removal method described in K081430. MaxFilter™ is intended to be used with Elekta Neuromag® MEG products in reducing measurement artifacts.

Elekta Neuromag® with active shielding non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning.

This premarket notification represents modifications made to our current product. Internal active shielding has been added to enhance the signal to noise ratio. The internal active shielding system is a magnetic shielding technique intended to be an integrated, optional part of Elekta Neuromag® magnetoencephalograph. The internal active shielding system increases the dynamic range of the magnetometers. related external magnetic interferences, by internal feedback compensation that uses the sensor array of the biomagnetometer as a zero indicator and compensation coils placed inside the magnetically shielded room to deliver a cancellation field for attenuating the interference.

The Elekta Neuromag® with Maxwell Filter non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning.

The Elekta Neuromag with Maxwell Filter adds support for separating brain signals from external disturbances and reducing mcasurements artifacts.

The Elekta Neuromag non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data in neurosurgical planning.

The Elekta Neuromag™ is an upgraded version of the currently available Neuromag Vectorview (K984401). The Elekta Neuromag™ does not change the intended use or the fundamental scientific technology of the Neuromag Vectorview. The Elekta Neuromag™ integrates 306 sensor elements, including planar gradiometers and and magnetometers, with computers and data acquisition and data analysis software in order to measure the differences in the magnetic signals generated by the intracellular dendritic currents. These detectors are positioned in a helmet shaped array that gives the user the ability to record the electrical activity of the entire surface of the brain simultaneously without having to move the position of the measuring device.