FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Brainsway Deep TMS System
K Number: K183303
·
Decision Mar 8, 2019
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
9
Applicant Total
11
Review Days
101
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Basic Information
- Device Name
- Brainsway Deep TMS System
- K Number
- K183303
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5802
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Brainsway , Ltd.
- Date Received
- November 27, 2018
- Decision Date
- March 8, 2019
- Product Code
- QCI
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QCI | Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | FDA class 2 | Neurology |
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Other Clearances by Brainsway , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251391 | BrainsWay Deep TMS System | Nov 7, 2025 | Substantially Equivalent |
| K251449 | BrainsWay Deep TMS System | Sep 13, 2025 | Substantially Equivalent |
| K222196 | Deep TMS System | May 31, 2024 | Substantially Equivalent |
| K220819 | BrainsWay Deep TMS System | Aug 26, 2022 | Substantially Equivalent |
| K210201 | Deep Transcranial Magnetic Stimulation (DTMS) System | Aug 17, 2021 | Substantially Equivalent |
| K203735 | Brainsway Deep TMS System | Apr 23, 2021 | Substantially Equivalent |
| K203616 | Brainsway Deep (DTMS) System | Apr 16, 2021 | Substantially Equivalent |
| K200957 | Brainsway Deep TMS System | Aug 21, 2020 | Substantially Equivalent |
| K173540 | Brainsway Deep (DTMS) System | May 3, 2018 | Substantially Equivalent |
| K122288 | BRAINSWAY DEEP TMS SYSTEM | Jan 7, 2013 | Substantially Equivalent |