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510(k) Data Aggregation
K Number
K993708Device Name
BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG
Manufacturer
BIOMAGNETIC TECHNOLOGIES, INC.
Date Cleared
1999-12-03
(30 days)
Product Code
OLX, GWQ, OLY
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
BIOMAGNETIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Magnes®3600 WH MEG is intended for use in diagnostic procedures that require the measurement and display of extracranial magnetic fields and information about the electrical activity in the brain as inferred from those fields.
Device Description
The Magnes® 3600 WH MEG consists of a magnetic sensor for detecting and measuring magnetic fields produced by the human brain, along with auxiliary equipment required to perform the measurements in a conventional medical facility environment and to display the results of the measurements to physicians in a variety of ways.
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K Number
K962317Device Name
MAGNES 2500 WH BIOMAGNETOMETER
Manufacturer
BIOMAGNETIC TECHNOLOGIES, INC.
Date Cleared
1997-05-07
(324 days)
Product Code
OLY
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
BIOMAGNETIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use of the Magnes 2500 WH is indicated for the patient whose physician believes that information about the magnetic fields produced by that patient's brain and information about the location of the sources of those magnetic fields could contribute to diagnosis or therapy planning.
Device Description
The Magnes 2500 WH biomagnetometer (hereafter "Magnes 2500 WH") comprises a magnetic sensor for detecting and measuring the magnetic fields produced by the human brain, along with the auxiliary equipment required to perform the measurements in a conventional medical facility environment and to display the results of the measurements to physicians in a variety of ways. The sensor utilizes an array of superconducting magnetic field pickup coils arranged in such a manner as to sense the magnetic fields over the portion of the skull enclosing the brain. For each such coil, a superconducting quantum interference device (SQUID) is used to detect the current induced in that coil by the brain magnetic field and produce a voltage proportional to the magnetic flux change. Conventional electronic and computer circuitry is used to amplify, filter, digitize, store and display the result of the measurement. The sensor includes an insulated reservoir of liquid helium as a refrigerant for cooling the superconducting components - pickup coils, SQUIDs, and interconnecting leads - to temperatures below their superconducting transition temperature. Heat is conducted from these superconducting elements along thermally conductive pathways into the helium reservoir. Provided as part of the Magnes 2500 WH biomagnetometer are the following ancillary items: Magnetically shielded room, comprised primarily of nickel-rich alloy and aluminum sheeting, to provide shielding from environmental sources of magnetic or ff noise. Manually operated non-magnetic gantry to place the sensor over the head of the patient in either a seated or supine position. Non-magnetic patient table with hydraulic elevation, to support the patient securely in either seated or supine position. Non-magnetic patient monitoring and communication devices, including video monitor, intercom, and head motion detector. Head shape and head position measurement system, to provide head shape and location relative to the sensor for data modeling and display. Computer workstation, operator console, and software to control system operation, data acquisition and storage, and data analysis and display. Sensory stimulus systems, to provide stimulation of the patient's somatosensory, auditory, y sumulus systems, to pro for magnetic measurement of evoked response.
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K Number
K941553Device Name
MAGNES II BIOMAGNETOMETER
Manufacturer
BIOMAGNETIC TECHNOLOGIES, INC.
Date Cleared
1996-05-16
(778 days)
Product Code
OLX, GWF, GWQ, OLY
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
BIOMAGNETIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Magnes II Biomagnetometer is intenced for use in diagnostic procedures that require the measurement and display of extracranial magnetic fields and information about the electrical activity of the brain as inferred from those fields.
Device Description
The Magnes II Biomagnetometer system utilizes superconducting signal pickup coils and Superconducting Quantum Interference Devices (SQUIDs) to detect and amplify magnetic fields produced by electrical activity in the brain. The signals are amplified, filtered and digitized by signal processing electronics. The digitized signals are computer processed to produce displays of information about biomagnetic field strength, direction, and location.
The Magnes II Biomagnetometer system consists of: Two sensor units, one ganty mounted and one floor mounted, which house the superconducting components which are cooled to liquid helium winperature, an electronics subsystem for preliminary analog signal amplification, filtering, and analog-to-digital conversion, a computer subsystem "master analysis processor" to store, process, and display the data, a magnetically shielded room for interference reduction, a patient table for subject/patient support, and a gantry for articulation of the upper sensor.
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