K251449
- 510(k) number
- K251449
- Device name
- BrainsWay Deep TMS System
- Applicant
- Brainsway , Ltd. IL
- Product code
- OBP — Transcranial Magnetic Stimulator
- Decision date
- 2025-09-13
- Date received
- 2025-05-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251449.pdf
Official FDA record: K251449
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.