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510(k) K193006

MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system by Tonica Elektronik A/S — Product Code QCI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2020
Date Received
October 28, 2019
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 Tonica Elektronik A/S

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  • K221544 — MagVenture TMS Atlas Neuro Navigation System (March 17, 2023)
  • K173620 — Mag Vita TMS Therapy System w/Theta Burst Stimulation (August 14, 2018)
  • K172667 — MagVita TMS Therapy w/MagPro R20 (October 5, 2017)
  • K171967 — MagVita TMS Therapy System (July 25, 2017)
  • K171481 — MagVita TMS Therapy System (June 16, 2017)
  • K170114 — MagVita TMS Therapy - w/MagPro R20 (May 1, 2017)

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)
  • K183303 — Brainsway Deep TMS System (March 8, 2019)
  • DEN170078 — Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System (August 17, 2018)