QKZ
- 产品代码
- QKZ
- 器械名称
- Magnetically Maneuvered Capsule Endoscopy System
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 876.1310
- FDA 专业组
- Gastroenterology, Urology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 2 件
- 其中 Summary 已存档
- 2 份,可直接下载
- FDA 历史累计 510(k)
- 6 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
A magnetically maneuvered capsule endoscopy system consists of an ingestible capsule and magnetic controller and is used for visualization of the stomach and duodenum. The ingestible capsule contains a camera that wirelessly captures images of the mucosa. The magnetic controller is used outside of the patient and is magnetically coupled with the capsule to control its location and viewing direction.
该代码近三年的 510(k)(2 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K241934 | 2024-07-31 | Anx Robotica Corp | NaviCam Xpress Stomach Capsule Endoscope System (Nav | |
| K231960 | 2023-10-03 | Anx Robotica Corporation | NaviCam Xpress Stomach Capsule Endoscope System (Nav |
FDA 官方分类页: QKZ
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。