QXR
- 产品代码
- QXR
- 器械名称
- Vaginal Hydrogel Packing System
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 892.5735
- FDA 专业组
- Radiology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 1 件
FDA 分类定义
A vaginal hydrogel packing system is a non-powered positioning device composed of a flexible container filled with a hydrogel. The device is intended to reduce the radiation dose delivered to adjacent pelvic organs by temporarily displacing the vaginal wall and adjacent pelvic tissues during radiation therapy treatment planning and delivery.
FDA 官方分类页： QXR
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。