Clearance Summary
BrainsWay Deep TMS System received FDA 510(k) clearance under submission number K251449, sponsored by Brainsway , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-09-13.
- Submission: K251449
- Applicant / Sponsor: Brainsway , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5805
- Decision date: 2025-09-13
Classification & Regulation
This clearance is catalogued under FDA product code OBP and 21 CFR 882.5805, within the Neurology review panel as a Class II device.