LMD

System, Digital Image Communications, Radiological

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.

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

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。