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510(k) Data Aggregation
K Number
DEN170078Device Name
Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System
Manufacturer
Brainways Ltd.
Date Cleared
2018-08-17
(322 days)
Product Code
QCI, OCI
Regulation Number
882.5802Why did this record match?
Applicant Name (Manufacturer) :
Brainways Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Brainsway Deep Transcranial Magnetic Stimulation System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder.
Device Description
The Brainsway DTMS System enables direct non-invasive activation of brain structures. TMS is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold, and is directed in an appropriate orientation relative to the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure.
The Brainsway DTMS System is composed of the following five main components:
- Electromagnetic Coil (HAC-Coil)
- TMS Neurostimulator
- Cooling System
- Positioning Device
- Personal Head Cap
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