QRN
- 产品代码
- QRN
- 器械名称
- Radiation Therapy Marking Device
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 892.5785
- 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)
- 2 件
FDA 分类定义
A radiation therapy marking device is a powered device that transdermally delivers a permanent or temporary colorant to the skin for the purpose of placing marks to guide radiation therapy. This classification does not include devices with reusable or reprocessed needles or devices intended for diagnostic, therapeutic, or aesthetic use or to deliver other products for these uses.
FDA 官方分类页： QRN
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。