510(k) Report

FDA applicant

Brainways, Ltd.

Har Hotzvim, IL1 decision2018–20180 recalls

FDA records 1 decision for Brainways, Ltd. (Har Hotzvim, IL) in 2018: 1 De Novo grant. All are in product code QCI (Transcranial Magnetic Stimulation System For…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Brainways, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Brainways, Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Brainways, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN170078Brainsway Deep Transcranial Magnetic Stimulation (DTMS) SystemBrainways, Ltd. · 20183cite it

What has FDA decided for it lately?

  • DEN170078Brainsway Deep Transcranial Magnetic Stimulation (DTMS) SystemBrainways, Ltd. · 2018

The one decision as Brainways, Ltd. →