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510(k) Data Aggregation
K Number
K152184Device Name
MagView BIOMAGNETOMETER SYSTEM
Manufacturer
TRISTAN TECHNOLOGIES, INC
Date Cleared
2016-04-08
(247 days)
Product Code
OLY
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
TRISTAN TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use of the Mag View Biomagnetometer is indicated for the patient whose physician believes that information about the magnetic fields produced by that patient's brain and information about the sources of those magnetic fields could contribute to diagnosis or therapy planning. The intended patient populations are neonates and those children with head circumferences of 50 cm or less.
Device Description
The Tristan Technologies MagView Biomagnetometer (hereinafter referred to as the "MagView") utilizes superconducting signal pickup coils and Superconducting Quantum Interference Devices (SQUIDs) to detect and amplify magnetic fields produced by electrical activity in brain. The MagView consists of a sensor unit, an electronics subsystem for preliminary amplification, filtering, and analog to digital conversion of the signals from each SOUID, an electronics rack containing power supplies to power the electronics subsystem, a computer to control the operation of the electronic subsystem and the SQUIDs and to acquire and store the signal values collected by the system.
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K Number
K151135Device Name
MODEL 621/624 BIOMAGNETOMETER
Manufacturer
TRISTAN TECHNOLOGIES, INC
Date Cleared
2016-03-15
(321 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
TRISTAN TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tristan Technologies Model 621/624 Biomagnetometer is intended for use as a tool that noninvasively measures and displays the magnetic signals produced by the electric currents in the heart of human beings of any age or in the heart of a fetus in utero.
Device Description
The Tristan Technologies Model 621/624 Biomagnetometer (hereinafter referred to as the "Model 621/624") utilizes superconducting signal pickup coils and Superconducting Quantum Interference Devices (SQUIDs) to detect and amplify magnetic fields produced by electrical activity in the heart. The Model 621/624 consists of a sensor unit, an electronics subsystem for preliminary amplification, filtering, and analog to digital conversion of the signals from each SQUID, an electronics rack containing power supplies to power the electronics subsystem, a computer to control the operation of the electronic subsystem and the SQUIDs and to acquire and store the signal values collected by the system.
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