LMD
- 产品代码
- LMD
- 器械名称
- System, Digital Image Communications, Radiological
- 管理类别
- 第 1 类(Class I)
- 21 CFR 条款
- 21 CFR 892.2020
- FDA 专业组
- Radiology
- 上市路径
- 豁免 510(k)(仍须遵守通用控制与注册列名)
- 该代码近三年的 510(k)
- 142 件
FDA 分类定义
A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions.
FDA 官方分类页: LMD
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。