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510(k) K183303

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2019
Date Received
November 27, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Device Class
Class II
Regulation Number
882.5802
Review Panel
NE
Submission Type

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 outside cerebral cortex (e.g., cerebellum).

Other clearances by Brainsway , Ltd.

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  • 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)
  • K200957 — Brainsway Deep TMS System (August 21, 2020)
  • K173540 — Brainsway Deep (DTMS) System (May 3, 2018)
  • K122288 — BRAINSWAY DEEP TMS SYSTEM (January 7, 2013)

Other clearances for product code QCI

  • K243459 — Ultimate rTMS for OCD (M-series) (April 17, 2025)
  • K230657 — BTL-99-OC (February 1, 2024)
  • K233742 — CloudTMS Edge for OCD (December 22, 2023)
  • K231350 — OCD MT Cap (85-00397-000) (June 8, 2023)
  • K221129 — CloudTMS for OCD (March 10, 2023)
  • K212289 — NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced T (May 6, 2022)
  • K193006 — MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system (August 9, 2020)
  • DEN170078 — Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System (August 17, 2018)