Fed Regist. 1998 Aug 24;63(163):44998.
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of April 29, 1998 (63 FR 23385). The document classified, along with other devices, the medical image storage device and medical image communications device. These devices were classified into Class I and were exempted from the requirement of premarket notification when they do not use irreversible data compression. The document was published with an incomplete device identification and description of the conditions for exemption from premarket notification. This document corrects those errors.
美国食品药品监督管理局（FDA）正在纠正一项于1998年4月29日出现在《联邦公报》（63 FR 23385）上的最终规则。该文件对医学图像存储设备和医学图像通信设备以及其他设备进行了分类。这些设备被归类为I类，并且在不使用不可逆数据压缩时可免于上市前通知要求。该文件发布时设备标识不完整，且对免于上市前通知的条件描述有误。本文件纠正了这些错误。
