FDA product code QCI: Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
QCI is the FDA product code for transcranial magnetic stimulation system for obsessive-compulsive disorder. It is a Class II device, regulated under 21 CFR 882.5802 and reviewed by the Neurology panel. FDA has cleared 8 510(k) submissions under QCI, 6 in the last five years, from 7 different applicants. The average 510(k) review took 194 days (median 223); 244 days on average over the last three years. 1 De Novo request was granted under it.
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).
Classification
| Field | Value |
|---|---|
| Device name | Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder |
| Device class | Class II |
| Regulation | 21 CFR 882.5802 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for QCI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 101 |
| 2020 | 1 | 286 |
| 2022 | 1 | 289 |
| 2023 | 3 | 129 |
| 2024 | 1 | 329 |
| 2025 | 1 | 160 |
Compare with all 510(k) review times · Search every QCI clearance
Top QCI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Teleemg, LLC | 2 | 2023-12-22 |
| Brain Ultimate, Inc. | 1 | 2025-04-17 |
| BTL Industries, Inc. | 1 | 2024-02-01 |
| Neuronetics | 1 | 2023-06-08 |
| Neuronetics, Inc. | 1 | 2022-05-06 |
2 more applicants have QCI clearances. See the full list in Caduvo.
Most recent QCI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243459 | Brain Ultimate, Inc. | Ultimate rTMS for OCD (M-series) | 2025-04-17 | 160 |
| K230657 | BTL Industries, Inc. | BTL-99-OC | 2024-02-01 | 329 |
| K233742 | Teleemg, LLC | CloudTMS Edge for OCD | 2023-12-22 | 30 |
| K231350 | Neuronetics | OCD MT Cap (85-00397-000) | 2023-06-08 | 30 |
| K221129 | Teleemg, LLC | CloudTMS for OCD | 2023-03-10 | 326 |
Recalls for QCI devices
openFDA lists no recalls for product code QCI.
Frequently asked questions
What is FDA product code QCI?
QCI is the FDA product code for transcranial magnetic stimulation system for obsessive-compulsive disorder. It is a Class II device, regulated under 21 CFR 882.5802 and reviewed by the Neurology panel.
What device class is QCI?
Class II, regulation 21 CFR 882.5802. Typical premarket route: 510(k).
How long does a 510(k) take for product code QCI?
Across 8 cleared submissions the average was 194 days from receipt to decision (median 223).
Which companies have the most QCI clearances?
Teleemg, LLC (2); Brain Ultimate, Inc. (1); BTL Industries, Inc. (1); Neuronetics (1); Neuronetics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QCI
- Run a recall and safety report across every QCI manufacturer
- Watch product code QCI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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