510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN170078Unknown

Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System

Brainways, Ltd., Har Hotzvim, IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN170078 is the FDA 510(k) clearance record for Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System, a class II device, cleared for Brainways , Ltd. on under FDA product code QCI (Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder). FDA's definition for product code QCI reads: "External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas...". FDA records list one 510(k) clearance for Brainways , Ltd. As of , FDA records show no recalls naming DEN170078.

Clearance record

Decision date
Received
(322 days to decision)
Product code
QCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Regulation
21 CFR 882.5802
Device class
Class II
Review panel
Neurology
Applicant
Brainways , Ltd. Bynet Bldg. P.O.B. 45169, Har Hotzvim, IL
Third party review
No

Clearances, product code QCI

Trailing 12 months

FDA records hold no clearances under product code QCI in the trailing twelve months.

FDA records show no clearances under product code QCI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QCI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260