BrainsWay Deep TMS System
K-Number: K251391 · 2025-11-07
ApplicantBrainsway , Ltd.
Decision Date2025-11-07
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
BrainsWay Deep TMS System is a medical device manufactured by Brainsway , Ltd.. It received FDA 510(k) clearance on 2025-11-07 under approval number K251391. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BrainsWay Deep TMS System?
BrainsWay Deep TMS System is a medical device that received FDA 510(k) clearance on 2025-11-07. It is manufactured by Brainsway , Ltd.. The 510(k) number is K251391.
When was BrainsWay Deep TMS System approved by the FDA?
BrainsWay Deep TMS System received FDA 510(k) clearance on 2025-11-07, under approval number K251391.
What company makes BrainsWay Deep TMS System?
BrainsWay Deep TMS System is manufactured by Brainsway , Ltd..
What is the FDA product code for BrainsWay Deep TMS System?
The FDA product code for BrainsWay Deep TMS System is OBP.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.