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510(k) Data Aggregation
K Number
K122288Device Name
BRAINSWAY DEEP TMS SYSTEM
Manufacturer
BRAINSWAY, LTD
Date Cleared
2013-01-07
(161 days)
Product Code
OBP
Regulation Number
882.5805Why did this record match?
Applicant Name (Manufacturer) :
BRAINSWAY, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Brainsway Deep TMS System is indicated for the treatment of depressive episodes in adult patients suffering from Major Depressive Disorder who failed to achieve satisfactory improvement from previous anti-depressant medication treatment in the current episode.
Device Description
The Brainsway Deep TMS (DTMS) System is intended for the treatment of depressive episodes in patients suffering from MDD. Transcranial magnetic stimulation (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 the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure. The Brainsway Deep TMS (DTMS) System is composed of the following main components: An Electromagnetic Coil (H1 Coil), A TMS Neurostimulator, A Cooling System, A Positioning Device, A cart.
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