Display Devices for Diagnostic Radiology  

Article No. 44900

Description

The Food and Drug Administration (FDA or “we”) is issuing this guidance to assist industry in preparing premarket notification submissions for display devices intended for use in diagnostic radiology.

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Synopsis

This document recommends what to include in a 510(k) submission for display devices in diagnostic radiology as identified by their classification regulation (21 CFR 892.2050) and product code (PGY). These devices are classified as class II devices that are intended to be used in controlled viewing conditions to display and view digital images for primary image interpretation. Display devices for diagnostic radiology may also be referred to as soft-copy displays or medical grade monitors.


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