MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy system
FDA 510(k) K193006 · Tonica Elektronik A/S
510(k) numberK193006
Submission
- Device name
- MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy system
- Applicant
- Tonica Elektronik A/S
Farum, DK - Received
- October 28, 2019
- Decision date
- August 9, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QCI – Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5802
- Specialty
- Neurology
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 510(k)s with product code QCI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243459 | Ultimate rTMS for OCD (M-series)QCI · Traditional | Brain Ultimate, Inc. | 04/17/2025SE |
| K230657 | BTL-99-OCQCI · Traditional | BTL Industries, Inc. | 02/01/2024SE |
| K233742 | CloudTMS Edge for OCDQCI · Special | Teleemg, LLC | 12/22/2023SE |
| K231350 | OCD MT Cap (85-00397-000)QCI · Special | Neuronetics | 06/08/2023SE |
| K221129 | CloudTMS for OCDQCI · Traditional | Teleemg, LLC | 03/10/2023SE |
| K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy…QCI · Traditional | Neuronetics, Inc. | 05/06/2022SE |
| K183303 | Brainsway Deep TMS SystemQCI · Traditional | Brainsway , Ltd. | 03/08/2019SE |
More from Brainsway , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260189 | MagVenture Accelerated TMS (aTMS) Therapy SystemOBP · Traditional | 05/22/2026SE |
| K251125 | MagVenture TMS Therapy SystemOBP · Traditional | 08/11/2025SE |
| K251119 | MagVenture TMS Therapy SystemOBP · Traditional | 08/08/2025SE |
| K252032 | T65 (9016E061-)OBP · Special | 07/30/2025SE |
| K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100…QPL · Traditional | 08/25/2023SE |
| K221544 | MagVenture TMS Atlas Neuro Navigation SystemHAW · Traditional | 03/17/2023SE |
| K173620 | Mag Vita TMS Therapy System w/Theta Burst StimulationOBP · Traditional | 08/14/2018SE |
| K172667 | MagVita TMS Therapy w/MagPro R20OBP · Special | 10/05/2017SE |
| K171967 | MagVita TMS Therapy SystemOBP · Special | 07/25/2017SE |
| K171481 | MagVita TMS Therapy SystemOBP · Special | 06/16/2017SE |
Questions and answers
When was MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy system cleared by the FDA?
MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy system (K193006) received a 510(k) decision of Substantially Equivalent on August 9, 2020, 286 days after the submission was received.
What is the product code of K193006?
The FDA product code is QCI – Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder, a Class II (moderate risk) device regulated under 21 CFR 882.5802.