QCIClass II
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
21 CFR 882.5802 / Neurology
QCI is the FDA product code for Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder, a class II device type, regulated under 21 CFR 882.5802. FDA's definition for this code reads: "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)". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QCI
- Device name
- Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
- 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).
- Regulation
- 21 CFR 882.5802
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 9
- Ingested recalls
- 0
Clearances, product code QCI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code QCI| Applicant | Clearances |
|---|---|
| Neuronetics Inc. | 2 |
| Teleemg, LLC | 2 |
| BTL Industries, Inc | 1 |
| Brain Ultimate, Inc. | 1 |
| Brainsway Ltd. | 1 |
| Brainways, Ltd. | 1 |
| Tonica Elektronik a/S | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.