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510(k) K200957

Brainsway Deep TMS System by Brainsway , Ltd. — Product Code QMD

K200957 is an FDA 510(k) premarket notification submitted by Brainsway , Ltd. for the device "Brainsway Deep TMS System". The FDA issued a decision of Substantially Equivalent on August 21, 2020. The device falls under product code QMD (Transcranial Magnetic Stimulation System For Smoking Cessation), a Class II device regulated under 21 CFR 882.5802. Brainsway , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2020
Date Received
April 9, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transcranial Magnetic Stimulation System For Smoking Cessation
Device Class
Class II
Regulation Number
882.5802
Review Panel
NE
Submission Type

Intended for use as a transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.

Other clearances by Brainsway , Ltd.

  • K251391 — BrainsWay Deep TMS System (November 7, 2025)
  • K251449 — BrainsWay Deep TMS System (September 13, 2025)
  • K222196 — Deep TMS System (May 31, 2024)
  • K220819 — BrainsWay Deep TMS System (August 26, 2022)
  • K210201 — Deep Transcranial Magnetic Stimulation (DTMS) System (August 17, 2021)
  • K203735 — Brainsway Deep TMS System (April 23, 2021)
  • K203616 — Brainsway Deep (DTMS) System (April 16, 2021)
  • K183303 — Brainsway Deep TMS System (March 8, 2019)
  • K173540 — Brainsway Deep (DTMS) System (May 3, 2018)
  • K122288 — BRAINSWAY DEEP TMS SYSTEM (January 7, 2013)

Other clearances for product code QMD

  • K203616 — Brainsway Deep (DTMS) System (April 16, 2021)

FDA data resources