510(k) K200957
- Device
- Brainsway Deep TMS System
- Applicant
- Brainsway Ltd.
- 510(k) number
- K200957
- Product code
- QCI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-08-21
- Date received
- 2020-04-09
- Regulation
- 882.5802
- Classification name
- Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ahava Stein
- Address
- 19 Hartom St. (Bynet Bldg) Har Hotzvim Jerusalem IL 9777518 9777518
FDA Registration Numbers#
- 3010300912
Source Documents#
Other 510(k) Records For Product Code QCI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243459 | Ultimate rTMS for OCD (M-series) | Brain Ultimate, Inc. | 2025-04-17 |
| K230657 | BTL-99-OC | BTL Industries, Inc. | 2024-02-01 |
| K233742 | CloudTMS Edge for OCD | Teleemg, LLC | 2023-12-22 |
| K231350 | OCD MT Cap (85-00397-000) | Neuronetics | 2023-06-08 |
| K221129 | CloudTMS for OCD | Teleemg, LLC | 2023-03-10 |
| K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar | Neuronetics, Inc. | 2022-05-06 |
| K193006 | MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system | Tonica Elektronik A/S | 2020-08-09 |
| K183303 | Brainsway Deep TMS System | Brainsway , Ltd. | 2019-03-08 |
| DEN170078 | Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System | Brainways , Ltd. | 2018-08-17 |
Legacy Summary#
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FDA Review#
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