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510(k) Data Aggregation
K Number
K203616Device Name
Brainsway Deep (DTMS) System
Manufacturer
Brainsway Ltd.
Date Cleared
2021-04-16
(127 days)
Product Code
QMD, QCI
Regulation Number
882.5802Why did this record match?
Product Code :
QMD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Brainsway Deep Transcranial Magnetic Stimulation System is indicated to be used as an aid in short-term smoking cessation for adults.
Device Description
The Brainsway Deep TMS System enables direct non-invasive activation of deep brain structures. 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 System is composed of the following main components:
1. Cart
a) TMS Neurostimulator
b) Cooling System
c) Positioning Device
2. Helmet
a) Aiming Apparatus (i.e., ruler/grid)
b) Electromagnetic Coil (H4-Coil)
c) Cap
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K Number
K200957Device Name
Brainsway Deep TMS System
Manufacturer
Brainsway Ltd.
Date Cleared
2020-08-21
(134 days)
Product Code
QMD, QCI
Regulation Number
882.5802Why did this record match?
Product Code :
QMD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Brainsway Deep Transcranial Magnetic Stimulation System is indicated to be used as an aid in short-term smoking cessation for adults.
Device Description
The Brainsway Deep TMS System enables direct non-invasive activation of deep brain structures. 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 scap. 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 FDA cleared Brainsway Deep TMS System is composed of the following main components:
- 1. Electromagnetic Coil
- 2. TMS Neurostimulator
- 3. Cooling System
- 4. Positioning System and Helmet
- 5. Cart
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