510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251391Substantially Equivalent

BrainsWay Deep TMS System

Brainsway Ltd., Jerusalem, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251391 is the FDA 510(k) clearance record for BrainsWay Deep TMS System, a class II device, cleared for Brainsway , Ltd. on under FDA product code OBP (Transcranial Magnetic Stimulator). FDA's definition for product code OBP reads: "A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the...". FDA records list 11 510(k) clearances for Brainsway , Ltd., from to . As of , FDA records show no recalls naming K251391.

Clearance record

Decision date
Received
(186 days to decision)
Product code
OBP Transcranial Magnetic Stimulator
Regulation
21 CFR 882.5805
Device class
Class II
Review panel
Neurology
Applicant
Brainsway , Ltd. 16 Hartom St. (Bynat Bldg), Jerusalem, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBP

Trailing 12 months
9 clearances under product code OBP in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OBP, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20261
March 20262
April 20260
May 20262
June 20260
July 20260
August 20262
September 20261
October 20260