FDA Image Management Classification Correction

FDA CDRH’s Federal Register Notice on August 24, 1998 issuing a correction to 21 CFR 892 Radiology devices: Classifications for five medical management devices. This corrects a statement in the original classification rule that erroneously exempts some of these devices from the design control requirements of the Quality System Regulation and correct some wording related to to irreversible data-compression. This classification regulation is related to picture archiving and communication systems (PACS) and various types of image-management, communications, and storage devices.

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