QCI
- 产品代码
- QCI
- 器械名称
- Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 882.5802
- FDA 专业组
- Neurology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 9 件
FDA 分类定义
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).
该代码近三年的 510(k)(3 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K243459 | 2025-04-17 | Brain Ultimate, Inc. | Ultimate rTMS for OCD (M-series) | |
| K230657 | 2024-02-01 | BTL Industries, Inc. | BTL-99-OC | |
| K233742 | 2023-12-22 | Teleemg, LLC | CloudTMS Edge for OCD |
FDA 官方分类页: QCI
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。