QCI — Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder Class II
Classification Details
- Product Code
- QCI
- Device Class
- Class II
- Regulation Number
- 882.5802
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243459 | brain ultimate | Ultimate rTMS for OCD (M-series) | April 17, 2025 |
| K230657 | btl industries | BTL-99-OC | February 1, 2024 |
| K233742 | teleemg | CloudTMS Edge for OCD | December 22, 2023 |
| K231350 | neuronetics | OCD MT Cap (85-00397-000) | June 8, 2023 |
| K221129 | teleemg | CloudTMS for OCD | March 10, 2023 |
| K212289 | neuronetics | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced T | May 6, 2022 |
| K193006 | tonica elektronik | MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy system | August 9, 2020 |
| K183303 | brainsway | Brainsway Deep TMS System | March 8, 2019 |
| DEN170078 | brainways | Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System | August 17, 2018 |