FDA.reportPublic FDA data

Deep Transcranial Magnetic Stimulation (DTMS) System

Primary DI
07290110537111
Brand
Deep Transcranial Magnetic Stimulation (DTMS) System
Company
BRAINSWAY LTD
Model
102
Device description
Deep TMS 102 system with H7
Published
2026-05-07
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive DisorderNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN170078000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170078000Brainsway Deep Transcranial Magnetic Stimulation (DTMS) SystemBrainways , Ltd.2018-08-17QCI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110537111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110537111072901105371117290110537111

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic neural stimulation systemAn assembly of electrically-powered devices intended for the treatment and/or diagnosis of neurological, psychiatric and/or cognitive conditions (e.g., Alzheimer's disease, major depressive disorder, pain) through noninvasive magnetic stimulation of the brain and/or peripheral nerves. It consists of an electromagnet with a control unit intended to produce electromagnetic field pulses to induce neurological electrical activity, and a patient chair; types intended for transcranial magnetic stimulation (TMS) may include cognitive training tools.

Regulatory Flags#

DUNS number
531873441
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290110537135Deep Transcranial Magnetic Stimulation (DTMS) System102/102B2026-05-07
07290110537142Deep Transcranial Magnetic Stimulation (DTMS) System102/102B2026-05-07
07290110538279Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-001-R2026-05-07
07290110538286Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-002-R2026-05-07
07290110530136Deep Transcranial Magnetic Stimulation (DTMS) System104HEL-01200D-CPLX2026-03-14
07290110530167Deep Transcranial Magnetic Stimulation (DTMS) System104HEL-07200D-CPLX2026-03-14
07290110530204Deep Transcranial Magnetic Stimulation (DTMS) System104HEL-04000D-CPLX2026-03-14
07290110533083Deep Transcranial Magnetic Stimulation (DTMS) System104CAP-000011-KIT2026-03-14
07290110533090Deep Transcranial Magnetic Stimulation (DTMS) System104CAP-000012-KIT2026-03-14
07290110533106Deep Transcranial Magnetic Stimulation (DTMS) System104CAP-000013-KIT2026-03-14
07290110533113Deep Transcranial Magnetic Stimulation (DTMS) System104CAP-000014-KIT2026-03-14
07290110537197Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-3042026-03-14
07290110537234Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-3012026-03-14
07290110538026Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-0012026-03-14
07290110538040Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-0022026-03-14
07290110538057Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-0302026-03-14
07290110538064Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-0312026-03-14
07290110538125Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-0072026-03-14
07290110538132Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-0332026-03-14
07290110538248Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-3072026-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290110538286Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-05-07
04260526050118Apollo TMS ProMAG & More GmbHQCI2026-04-09
07290110530167Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-03-14
07290110538040Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-03-14
07290110538064Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-03-14
07290110538248Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-03-14
00850005944935NeuroStar HeadrestNEURONETICS, INC.QCI2025-12-15
05713484031440MagPro accessoriesTonica Elektronik A/SQCI2025-12-11
00850005944911NeuroStar HeadrestNEURONETICS, INC.QCI2025-12-09
00850005944850NeuroStar Advanced Therapy SystemNEURONETICS, INC.QCI2025-06-24
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00850005944874NeuroStar Advanced Therapy SystemNEURONETICS, INC.QCI2025-06-24
00850005944829NeuroStar Advanced Therapy SystemNEURONETICS, INC.QCI2025-05-08
00850005944836NeuroStar Advanced Therapy SystemNEURONETICS, INC.QCI2025-05-08
00850005944812NeuroStar Advanced Therapy SystemNEURONETICS, INC.QCI2025-05-07
06430063200187Nexstim NBS SystemNexstim OyjQCI2025-04-01
05713484030214MagPro accessoriesTonica Elektronik A/SQCI2025-03-13
05713484030023MagPro accessoriesTonica Elektronik A/SQCI2025-03-12
05713484031426MagPro AccessoriesTonica Elektronik A/SQCI2025-03-12
04260526050101Apollo Light TMS Therapy SystemMAG & More GmbHQCI2024-08-21
00850005944638SenStar Treatment LinkNEURONETICS, INC.QCI2024-08-02
00850005944652SenStar Connect Treatment LinkNEURONETICS, INC.QCI2024-08-02
00850005944041Arm Support Cushion, GrayNEURONETICS, INC.QCI2024-02-02
00850005944164Wedge Cushion, GrayNEURONETICS, INC.QCI2024-02-02
00850005944171Head Cushion Insert Set, GrayNEURONETICS, INC.QCI2024-02-02
00850005944188Arm Support Cushion, BlueNEURONETICS, INC.QCI2024-02-02
00850005944416Wedge Cushion, BlueNEURONETICS, INC.QCI2024-02-02
00850005944492Head Cushion Insert Set, BlueNEURONETICS, INC.QCI2024-02-02
04650075335895CloudTMS Edge for OCDNEUROSOFT, OOOQCI2024-01-12
04650075335932CoudTMS Edge for OCDNEUROSOFT, OOOQCI2024-01-12