FDA.reportPublic FDA data

Deep Transcranial Magnetic Stimulation (DTMS) System

Primary DI
07290110538040
Brand
Deep Transcranial Magnetic Stimulation (DTMS) System
Company
BRAINSWAY LTD
Model
104
Catalog number
SYS-104-002
Device description
Deep TMS 104 system with H7
Published
2026-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBPTranscranial Magnetic StimulatorNeurology2
QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive DisorderNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183303000
K220819000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183303000Brainsway Deep TMS SystemBrainsway , Ltd.2019-03-08QCI
K220819000BrainsWay Deep TMS SystemBrainsway , Ltd.2022-08-26OBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110538040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110538040072901105380407290110538040

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height205Centimeter
Length68Centimeter
Weight161Kilogram
Width68.8Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

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
07290110537111Deep Transcranial Magnetic Stimulation (DTMS) System1022026-05-07
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
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

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Primary DI, Brand, Company table
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10850005944963Hygiene Barrier, 50 PackNEURONETICS, INC.OBP2026-10-21
10850005944970Strap, Head PositioningNEURONETICS, INC.QCI2026-10-21
10850005944970Strap, Head PositioningNEURONETICS, INC.OBP2026-10-21
G792699APM21MUS00EXOMIND applicatorBTL INDUSTRIES FZEOBP2026-10-09
G792699HEADREST1MUS00HeadrestBTL INDUSTRIES FZEOBP2026-10-09
G792699PO2M21MUS00EXOMINDBTL INDUSTRIES FZEOBP2026-10-09
B108699APM1MUS00EXOMIND Dual applicatorBTL INDUSTRIES LIMITEDQCI2026-08-25
B108699APM1MUS00EXOMIND Dual applicatorBTL INDUSTRIES LIMITEDOBP2026-08-25
06971538581788NeuronavigatorShenzhen Yingzhi Technology Co.,Ltd.OBP2026-08-21
07290110537111Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-05-07
07290110537135Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
07290110538279Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
07290110538286Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-05-07
07290110538286Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
04260526050118Apollo TMS ProMAG & More GmbHOBP2026-04-09
04260526050118Apollo TMS ProMAG & More GmbHQCI2026-04-09
07290110530136Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110530167Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-03-14
07290110530167Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110533083Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110533090Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110533106Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110533113Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110537234Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
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07290110538057Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538064Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14