Brainsway Deep (DTMS) System— 510(k) K173540

Name: FDA 510(k) clearance K173540
Creator: U.S. Food and Drug Administration
Published: 2018-05-03

Substantially Equivalent

Brainsway , Ltd.

FDA 510(k) clearance K173540 for Brainsway Deep (DTMS) System, Substantially Equivalent on 2018-05-03. Applicant: Brainsway , Ltd.. Device class: 2.

Clearance details

Applicant: Brainsway , Ltd.
Product code: Code OBP
Device class: Class 2
Regulation: 21 CFR 882.5805
Advisory panel: Neurology
Date received: 2017-11-15
Decision date: 2018-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jerusalem, IL

Download summary PDF View on FDA.gov ↗

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K260189 — MagVenture Accelerated TMS (aTMS) Therapy System2026-05-22
K260560 — Apollo TMS Therapy System; Apollo light TMS Therapy System2026-05-22

More clearances from Brainsway , Ltd.

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K251391 — BrainsWay Deep TMS System2025-11-07
K251449 — BrainsWay Deep TMS System2025-09-13
K222196 — Deep TMS System2024-05-31
K220819 — BrainsWay Deep TMS System2022-08-26
K210201 — Deep Transcranial Magnetic Stimulation (DTMS) System2021-08-17

Adverse events under product code OBP

product code OBP

Injury: 270
Total: 270

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.