K251391
- 510(k) number
- K251391
- Device name
- BrainsWay Deep TMS System
- Applicant
- Brainsway , Ltd. IL
- Product code
- OBP — Transcranial Magnetic Stimulator
- Decision date
- 2025-11-07
- Date received
- 2025-05-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K251391.pdf
Official FDA record: K251391
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.