QCI
9 FDA 510(k) clearances · Product code
286 daysmedian time to decision
329 days90th percentile
9clearances measured
FDA profile
- Official device name
- Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5802
- Medical specialty
- Neurology
- FDA 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).
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| Record | Firm | Date |
|---|---|---|
| Ultimate rTMS for OCD (M-series) (K243459) | Brain Ultimate, Inc. | 2025-04-17 |
| BTL-99-OC (K230657) | BTL Industries, Inc. | 2024-02-01 |
| CloudTMS Edge for OCD (K233742) | Teleemg, LLC | 2023-12-22 |
| OCD MT Cap (85-00397-000) (K231350) | Neuronetics | 2023-06-08 |
| CloudTMS for OCD (K221129) | Teleemg, LLC | 2023-03-10 |
| NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar (K212289) | Neuronetics, Inc. | 2022-05-06 |
| MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system (K193006) | Tonica Elektronik A/S | 2020-08-09 |
| Brainsway Deep TMS System (K183303) | Brainsway , Ltd. | 2019-03-08 |
| Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System (DEN170078) | Brainways , Ltd. | 2018-08-17 |
Track QCI automatically
Every clearance here is in the API, with alerts when new ones post.