FDA Image Management Classification Rule

FDA CDRH’s 21 CFR 892 Radiology Devices: classification of Five Medical Image-management Devices (MIMS). This classification regulation is related to picture archiving and communication systems (PACS) and various types of image-management, communications, and storage devices and defines which types of devices are exempt from 510(k) submissions. Note there was a correction issued on August 24, 1998 for this rule.

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