Fed Regist. 1998 Apr 29;63(82):23385-7.
The Food and Drug Administration (FDA) is classifying five radiology devices that provide functions related to medical image communication, storage, processing, and display into class I (general controls) or class II (special controls). The medical image storage device and medical image communications device are classified into class I, and they are exempted from the requirement of premarket notification when they do not use irreversible compression. The medical image digitizer, the medical image hardcopy device, and the picture archiving and communications system are classified into class II. These actions are being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 and the Safe Medical Devices Act of 1990.
美国食品药品监督管理局（FDA）正在将五种提供与医学图像通信、存储、处理和显示相关功能的放射学设备归类为I类（一般控制）或II类（特殊控制）。医学图像存储设备和医学图像通信设备被归类为I类，当它们不使用不可逆压缩时，可免于上市前通知的要求。医学图像数字化仪、医学图像硬拷贝设备和图像存档与通信系统被归类为II类。这些行动是根据经1976年《医疗器械修正案》和1990年《安全医疗器械法》修订的《联邦食品、药品和化妆品法案》（该法案）采取的。
